MAUDE Adverse Event Report: STRYKER SPINE-US 10X23X12DEG-9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950102
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an l2/l3 tiif surgery, the cage backed out of the implanted space.The patient underwent revision surgery to remove the cage.
Event or Problem Description
It was reported that after an l2/l3 tiif surgery, the cage backed out of the implanted space.The patient underwent revision surgery to remove the cage.
Additional Manufacturer Narrative
Method: risk assessment.Results: the reported event was confirmed via correspondence.Visual, dimensional and functional analysis could not be performed as the device was not returned.X-ray images were not provided.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that the cage size was not appropriate in the surgeon¿s opinion and that a non-stryker system was installed as supplemental fixation.Conclusion: the potential root cause of the reported event is inappropriate cage size used for the patient.

• Brand Name: 10X23X12DEG-9
• 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: 7674375
• Report Number: 3004024955-2018-00040
• Device Sequence Number: 16355910
• Product Code: MAX
• UDI-Device Identifier: 07613327295023
• UDI-Public: 07613327295023
• Combination Product (Y/N): N
• PMA/510(K) Number: K162262
• 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): 09/24/2018

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: No Information
• Device Catalogue Number: 48950102
• Device Lot Number: D7MJ1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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