MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 1 LEVEL ACP SIZE 20MM; IMPLANT-CERVICAL PLATE

Catalog Number 48651120

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported that plate remaining at c5-6, using reflex hybrid to fuse c6-7.The surgeon trying to use same holes realized that the ring on plates failed.There was a delay about 5 minutes.

Manufacturer Narrative

Method: device history review; complaint history review; results: the stryker rep confirmed that this was a revision surgery of a competitor's plate to extend fusion to the c6-c7 vertebrae.The rep reported that the surgeon initially used the existing holes from the competitor's plate, however this is where the screws deformed the locking ring on the stryker plate due to over-angulation (the recommended angulation is outlined in the surgical technique) of the screws in the existing holes.A new plate with new holes was successfully implanted.Conclusion: the returned reflex-hybrid 1 level acp was confirmed to have a deformed locking ring.Manufacturing records for this product were reviewed and no incidents were found.This was the first reported event for this lot.No new harms/severities were reported.

Event Description

It was reported that plate remaining at c5-6, using reflex hybrid to fuse c6-7.The surgeon trying to use same holes realized that the ring on plates failed.There was a delay about 5 minutes.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 20MM
• Type of Device: IMPLANT-CERVICAL PLATE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3838733
• MDR Text Key: 4615586
• Report Number: 0009617544-2014-00239
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48651120
• Device Lot Number: 072857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1