MAUDE Adverse Event Report: STRYKER SPINE-US 8MM X 0DEG X 9MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48952080
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage fractured post operatively.However, the patient has no pain or adverse consequences.No revision surgery planned.
Additional Manufacturer Narrative
The lot number was corrected to aaa4.Visual, dimensional, functional, and materials analyses could not be performed because the device remains implanted.Device history records were reviewed and all units met specification.The reported event of cage fracture was confirmed via x-ray images.The supplemental fixation system shows no sign of damage; therefore, it is possible the fracture was initiated during implantation.Because the device remains implanted and is not available for analysis the root cause cannot be determined conclusively.
Event or Problem Description
Physician reported a post-operative cage fracture.There has been no adverse consequence to the patient and revision surgery is not deemed necessary at this time.

• Brand Name: 8MM X 0DEG X 9MM 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: 8479190
• Report Number: 3004024955-2019-00008
• Device Sequence Number: 14125678
• Product Code: MAX
• UDI-Device Identifier: 07613327117738
• UDI-Public: 07613327117738
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 48952080
• Device Lot Number: AAA4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1