MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	400010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	02/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon post-op follow up, surgeon determined via x ray that the cage appeared to have collapsed.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: as per surgical technique ''the surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity, trauma, and that the device may need to be replaced in the future.'' it was reported that implant reduction of height was noticed after patient reinjured back and fall against his truck.It is possible that this fall resulted in inordinate stress upon the implant which may have contributed to device failure.Conclusion: the reported device remains implanted therefore a plausible root cause cannot be identified conclusively.
Event or Problem Description
It was reported that upon post-op follow up, surgeon determined via x ray that the cage appeared to have collapsed.
Additional Manufacturer Narrative
Lot #: 10081302.Implant date: (b)(6) 2015.Method:x-rays and medical records analysis results: per x-rays review, the implant appears to be snugly fit and placed well, supplemental fixation was used as indicated in surgical technique.Post-op x-rays show cage at l5-s1 too far posterior what may have contributed to implant migration post-op.Voluntary recall was initiated in (b)(6) 2016 for all acculif pl cages.For patients who have had an acculif posterior lumbar (pl) expandable interbody implant, stryker spine is recommending routine clinical and radiographic post-operated evaluation.Should the patient report any change in or develop near-onset symptoms, more urgent clinical and radiographic evaluation should be completed.
Event or Problem Description
It was reported that upon post-op follow up, surgeon determined via x ray that the cage appeared to reduced in height.

• Brand Name: ACCULIF PL 10-16MM X11MM X 27 MM X 8 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5478539
• Report Number: 3004024955-2016-00019
• Device Sequence Number: 299531
• Product Code: MAX
• UDI-Device Identifier: 07613327066777
• UDI-Public: 07613327066777
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 400010
• Device Lot Number: 10081302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2016
• Supplement Date Received by Manufacturer: Not provided; 03/19/2018
• Initial Report FDA Received Date: 03/03/2016
• Supplement Report FDA Received Date: 07/22/2016; 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR