MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS SPACER 8 X 25 X 4 DEG - 8; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 6765084

Device Problem Difficult To Position (1467)

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

Event Date 01/08/2015

Event Type  malfunction  

Event Description

It was reported that; during oic peek surgery, the cage could not be assembled to inserter straightly.The surgeon used other cage and finished the surgery.

Manufacturer Narrative

Method: device history review and device inspection.Results: no relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Visual inspection indicated the returned peek implant has deformed threads on the posterior end of the implant.This posterior threaded hole is intended to mate with the threaded tip of the implant inserter.There is no damage to the anterior threaded hold of the implant.Conclusion: the plausible root cause of the event is user related - specifically crossthreading of the implant and inserter.

Event Description

It was reported that; during oic peek surgery, the cage could not be assembled to inserter straightly.The surgeon used other cage and finished the surgery.

• Brand Name: AVS SPACER 8 X 25 X 4 DEG - 8
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4460959
• MDR Text Key: 17577257
• Report Number: 0009617544-2015-00041
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6765084
• Device Lot Number: 71668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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