MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 6DEG X 11MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48951076
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device still remained implanted in the patient.
Event or Problem Description
It was reported that the cage fractured post-operatively.No adverse consequence to the patient was reported.As per conversation with the surgeon, he thinks that the fracture could have been initiated during insertion which might have contributed to the event.
Event or Problem Description
It was reported that the cage fractured post-operatively.No adverse consequence to the patient was reported.As per conversation with the surgeon, he thinks that the fracture could have been initiated during insertion which might have contributed to the event.
Additional Manufacturer Narrative
Method: x-ray image review, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via x-ray image received from sales rep.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Product was not received as it is implanted in the patient so an evaluation was not possible.Conclusion: the most likely cause of the reported event was determined to be user error: formation of small crack during intra-operative insertion-> fracture propagates throughout cyclic loading.Device still in the patient.

• Brand Name: 7MM X 6DEG X 11MM X 23MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8146640
• Report Number: 3004024955-2018-00057
• Device Sequence Number: 16536476
• Product Code: MAX
• UDI-Device Identifier: 07613327117523
• UDI-Public: 07613327117523
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: Health Professional
• Device Catalogue Number: 48951076
• Device Lot Number: DHET
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR