MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL 6-9 MM X 11 MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	305006
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the cage was inserted and positioned and the would expand at all.Checked the o rings of syringe body and plunger both were in tact checked the tubing on both ends and nothing was damaged also retorqued the interbody down before expanding a second time and the cage was still unable to expand.Each implant was left unexpanded, used fixation (pedicle screw) and pressed down posteriorly to prevent implant moving.There are no report of any revision surgeries, no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the implant remains implanted and is not available for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: because x-rays showing implant placement were provided and the cage was not returned for evaluation the root cause could not be determined conclusively.
Event or Problem Description
It was reported that; the cage was inserted and positioned and the would expand at all.Checked the o rings of syringe body and plunger both were in tact checked the tubing on both ends and nothing was damaged also retorqued the interbody down before expanding a second time and the cage was still unable to expand.Each implant was left unexpanded, used fixation (pedicle screw) and pressed down posteriorly to prevent implant moving.There are no report of any revision surgeries, no adverse consequences or surgical delay reported.

• Brand Name: ACCULIF TL 6-9 MM X 11 MM X 34 MM X 0 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5972737
• Report Number: 3004024955-2016-00083
• Device Sequence Number: 488126
• Product Code: MAX
• UDI-Device Identifier: 07613327068030
• UDI-Public: (01)07613327068030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 305006
• Device Lot Number: 10201506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR