MAUDE Adverse Event Report: STRYKER SPINE-US TRITANIUM PL 12MM X 28MM X6DEG - 9MM POSTERIOR LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48954126
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/06/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor was inserting a cage into a disc space using a rotate and turn technique utilizing a custom inserter when the graft broke.He was under bilateral screw distraction at the time and had shaved the disc space to the corresponding cage height.The doctor left the broken segment in the space and back filled with bone.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual insp and correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be torsional overload while applying the torsion insertion technique; and the use of specialty inserter, which has two added protrusion features comparing with the standard inserter which will exacerbate the breakage during twist insertion.
Event or Problem Description
It was reported that the doctor was inserting a cage into a disc space using a rotate and turn technique utilizing a custom inserter when the graft broke.He was under bilateral screw distraction at the time and had shaved the disc space to the corresponding cage height.The doctor left the broken segment in the space and back filled with bone.

• Brand Name: TRITANIUM PL 12MM X 28MM X6DEG - 9MM 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: 5756193
• Report Number: 3004024955-2016-00069
• Device Sequence Number: 435643
• Product Code: MAX
• UDI-Device Identifier: 07613327117998
• UDI-Public: (01)07613327117998
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2016

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: 48954126
• Device Lot Number: AAAE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR