Events

Rappel de Device Recall Manta Ray ACP System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Theken Spine Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56502
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0087-2011
  • Date de mise en oeuvre de l'événement
    2010-07-29
  • Date de publication de l'événement
    2010-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93807
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Cause
    The manta ray cervical system was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures.
  • Action
    Integra sent a Technical Bulletin dated July 29, 2010 via Fedex to their customers. The bulletin identified the product, the problem, and action to be taken by the user/customers (surgeons) of the two (2) reported instances of screws backing out of the plates. The Bulletin provided instructions outlining the proper surgical techniques for implantation of screws using the Manta Ray ACP System. The bulletin also included an attached acknowledgement form which the user/customers were asked to complete and FAX to (609) 275-5363 or E-mail back to the E-mail address provided. The form verified that each customer: 1) received the technical bulletin; and 2) has read and understood the proper technique for surgical placement of the screws as outlined in the bulletin. For technical support customers were to contact the Customer Service Department at (866) 942-8698.

Device

Device Recall Manta Ray ACP System
  • Modèle / numéro de série
    A total of 136 Catalog Numbers of the suspect device were affected by the firm's corrective action. They are as follows:   22-10-0118 22-10-0366 22-12-4016 22-17-4515 22-20-0351 22-21-4017 22-10-0120 22-10-0369 22-12-4018 22-17-4517 22-20-0354 22-21-4018 22-10-0122 22-10-0372 22-13-4513 22-18-4513 22-20-0357 22-22-4511 22-10-0124 22-10-0375 22-13-4515 22-18-4515 22-20-0360 22-22-4513 22-10-0126 22-10-0468 22-13-4517 22-18-4517 22-20-0363 22-22-4515 22-10-0128 22-10-0472 22-14-4513 22-20-0118 22-20-0366 22-22-4517 22-10-0130 22-10-0476 22-14-4515 22-20-0120 22-20-0369 22-22-4519 22-10-0132 22-10-0480 22-14-4517 22-20-0122 22-20-0372 22-23-4010 22-10-0134 22-10-0484 22-15-4010 22-20-0124 22-20-0375 22-23-4011 22-10-0231 22-10-0488 22-15-4012 22-20-0126 22-20-0468 22-23-4012 22-10-0234 22-10-0492 22-15-4013 22-20-0128 22-20-0472 22-23-4013 22-10-0237 22-11-4010 22-15-4014 22-20-0130 22-20-0476 22-23-4014 22-10-0240 22-11-4012 22-15-4015 22-20-0132 22-20-0480 22-23-4015 22-10-0243 22-11-4013 22-15-4016 22-20-0134 22-20-0484 22-23-4016 22-10-0246 22-11-4014 22-15-4018 22-20-0231 22-20-0488 22-23-4017 22-10-0249 22-11-4015 22-16-4010 22-20-0234 22-20-0492 22-23-4018 22-10-0252 22-11-4016 22-16-4012 22-20-0237 22-21-4010 22-24-4511 22-10-0348 22-11-4018 22-16-4013 22-20-0240 22-21-4011 22-24-4513 22-10-0351 22-12-4010 22-16-4014 22-20-0243 22-21-4012 22-24-4515 22-10-0354 22-12-4012 22-16-4015 22-20-0246 22-21-4013 22-24-4517 22-10-0357 22-12-4013 22-16-4016 22-20-0249 22-21-4014 22-24-4519 22-10-0360 22-12-4014 22-16-4018 22-20-0252 22-21-4015  22-10-0363 22-12-4015 22-17-4513 22-20-0348 22-21-4016
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution - USA including AL, AZ, CA, CT, FL, GA, HI, IL, ID, IN, KS, LA, MI, MD, MN, MA, MD, MS, NE, NY, NC, NJ, NV, NM, OH, OR, OK, PA, TN, TX, UT, WI, and WA.WA.
  • Description du dispositif
    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. || Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.
  • Manufacturer
    Theken Spine Llc

Manufacturer

Theken Spine Llc
  • Adresse du fabricant
    Theken Spine Llc, 1800 Triplett Blvd, Akron OH 44306-3311
  • Société-mère du fabricant (2017)
    Theken Spine Llc
  • Source
    USFDA