MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
It was reported that a tritanium pl cage fractured during implantation.There was no adverse consequence to the patient.The broken component remains in the patient and the procedure was completed successfully following a 10-minute delay.
Event or Problem Description
It was reported that a tritanium pl cage fractured during implantation.There was no adverse consequence to the patient.The broken component remains in the patient and the procedure was completed successfully following a 10-minute delay.Revision surgery will not be performed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history record's were reviewed for this lot, 1 similar complaint was identified.It was reported that the implant was not inserted at difficult angle, excess in-line force was applied on the cage, higher than normal impaction force was applied to the inserter, difficulty with impaction/insertion of the cage was experienced.Trialing was performed using 2mm undersized from implant.Patient did not have a particularly tight disc space.Disc was prepared using pituitary, kerrison, curettes, shaver use.Dbm bone graft was placed in the cage.Graft was loaded by hand, impaction was not applied.Patient had normal bone quality.Since the device was not returned, an exact cause of the reported event could not be determined.Excess insertion force may have contributed to the event.

• Brand Name: 9MM X 6DEG X11MM 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: 11939190
• Report Number: 3004024955-2021-00008
• Device Sequence Number: 19913125
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: 07613327118070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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 Model Number: 48955096
• Device Catalogue Number: 48955096
• Device Lot Number: AKJ6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1