MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 11MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE.

Model Number	48951096
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Cage main body fracture intra-op was confirmed via visual inspection, x-ray images and correspondence.Conclusion: the root causes of the reported cage fracture include: (1) no distraction was applied during cage insertion; (2) applied cantilever force.
Event or Problem Description
It was reported that plif was done at l3-5.When inserting the cage in the procedure of the monopotal plf and straightening the diagonal cage using the impactor, it broke at the grip portion behind the cage.After that, the remained cage was tried to be removed with punch, but the cage was broken and only the fragments were removed, therefore, the vertebrae was scraped and made spade in the cage part and it was removed.After that, the cage was implanted with bipolar plf and the operation was succeeded.

• Brand Name: 9MM X 6DEG X 11MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7099457
• Report Number: 3004024955-2017-00041
• Device Sequence Number: 11071458
• Product Code: MAX
• UDI-Device Identifier: 07613327117561
• UDI-Public: (01)07613327117561(11)161208(10)AY26
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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 Model Number: 48951096
• Device Catalogue Number: 48951096
• Device Lot Number: AY26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/08/2017
• 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: Other