MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 305008

Device Problems Collapse (1099); Disassembly (1168)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 03/14/2016

Event Type  Injury  

Event Description

It was reported that; original dos (b)(6) 2016, on (b)(6) 2016 patient presented x-rays taken "possible device collapsed", revision surgery done on (b)(6) 2016.Device removed, unknown whether it had collapsed.Implant finally obtained from risk management on (b)(6) 2016.Additional information: patient came for a follow up visit 2 weeks after the surgery and x-rays revealed vertebral body fracture.The implant was still expanded.According to sales rep, cage loss in height approximately 1 mm.

Manufacturer Narrative

Results: the reported event of post-op loss of height of the cage cannot be confirmed.Visual inspection of the explanted device was performed and revealed that the implant is still expanded approximately 2 mm.According to the sales rep doctor seems to believe that the implant settled 1 mm and locked.Per acculif surgical technique, if the implant was not fully expanded to the next millimeter increment, the implant will settle back down to the lower millimeter increment.Settling up to1mm is normal and does not indicate a failure of the device.Conclusion: failure of the implant could not be confirmed conclusively therefore a plausible root cause could not be identified.

Event Description

It was reported that; original dos (b)(6) 2016, on (b)(6) 2016 patient presented x-rays taken "possible device collapsed", revision surgery done on (b)(6) 2016.Device removed, unknown whether it had collapsed.Implant finally obtained from risk management on (b)(6) 2016.Additional information: patient came for a follow up visit 2 weeks after the surgery and x-rays revealed vertebral body fracture.The implant was still expanded.According to sales rep, cage loss in height approximately 1 mm.

• Brand Name: ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5568662
• MDR Text Key: 42416217
• Report Number: 3004024955-2016-00043
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 305008
• Device Lot Number: 04141506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 159