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 Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while inserting the device in a collapsed disc space the back of the implant fractured.The instrument to implant interface was misaligned about 15 degrees and wasn't straight vertical due to the anatomy.While the surgeon was malleting into disc space the implant fractured/sheared about 7mm from the proximal end into the teeth of the cage.There were no safety issues to the patient, so surgeon left the cage implanted.The broken piece was removed and a bone filler was used.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The patient had a "collapsed" disc space and lot of lordosis.The implant was impacted by mallet at an angle due to patient's anatomy.Conclusion: the plausible root cause of reported event was determined to be user or patient¿s related.
Event or Problem Description
It was reported that; while inserting the device in a collapsed disc space the back of the implant fractured.The instrument to implant interface was misaligned about 15 degrees and wasn't straight vertical due to the anatomy.While the surgeon was malleting into disc space the implant fractured/sheared about 7mm from the proximal end into the teeth of the cage.There were no safety issues to the patient, so surgeon left the cage implanted.The broken piece was removed and a bone filler was used.

• 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: 6015259
• Report Number: 3004024955-2016-00093
• Device Sequence Number: 10849732
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: (01)07613327118070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/13/2016

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: A97Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1