MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 0DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48953090
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 2 screws pulled out of vertebral body and interbody cage migrated from original position.Patient required revision surgery.
Event or Problem Description
It was reported that 2 screws pulled out of vertebral body and interbody cage migrated from original position.Patient required revision surgery.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the root cause of the reported event is due to the supplemental fixation system (screws) pulling out.

• Brand Name: 9MM X 0DEG X 11MM X 28MM
• 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: 7573021
• Report Number: 3004024955-2018-00033
• Device Sequence Number: 18886421
• Product Code: MAX
• UDI-Device Identifier: 07613327117851
• UDI-Public: (01)07613327117851
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• 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): 09/28/2018

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: Health Professional
• Device Model Number: 48953090
• Device Catalogue Number: 48953090
• Device Lot Number: D58N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: Required Intervention
• Patient Age: 58 YR