MAUDE Adverse Event Report: STRYKER SPINE-US TRITANIUM PL 9MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48955096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was doing a high s1 case and had trouble advancing the cage, the surgeon had to twist the cage to insert; while twisting the cage during insertion, the cage broke along the skinny part of the graft window (was not in the disc space).It appears that when twisting the cage, the nose got caught in the sacrum and the cage broke.The surgeon was performing a revision of a competitor's product.Same size cage was used to complete the procedure.No adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual insp, x-ray images and correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.No distraction was applied prior to the cage insertion and no trial was used for the disc space sizing.Conclusion: the most likely cause of the cage nose jamming exacerbating the cage fracture under rotational force was determined to be related to not opening up enough disc space prior to the cage insertion.
Event or Problem Description
It was reported that the surgeon was doing a high s1 case and had trouble advancing the cage, the surgeon had to twist the cage to insert; while twisting the cage during insertion, the cage broke along the skinny part of the graft window (was not in the disc space).It appears that when twisting the cage, the nose got caught in the sacrum and the cage broke.The surgeon was performing a revision of a competitor's product.Same size cage was used to complete the procedure.No adverse consequences to the patient.

• Brand Name: TRITANIUM PL 9MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5877365
• Report Number: 3004024955-2016-00077
• Device Sequence Number: 626370
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: (01)07613327118070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/22/2016

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: 48955096
• Device Lot Number: AE2H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1