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

Model Number	48951076
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devices remains implanted.
Event or Problem Description
It was reported that during intra-operative placement of a tritanium pl cage, the cage fell anterior to the vertebral body.The surgeon then attempted to remove the cage from behind but could not.The surgery was completed by leaving the cage in place.Revision surgery is not planned at this time but the possibly will be revisited in the future.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned because it remains implanted in the patient.Device and complaint history were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that the tritanium pl cage was inserted from the left side but fell anterior to the vertebral body.The surgeon tried to remove the cage from behind, but it couldn't be removed.The patient's condition was reported to not be bad, and the plif was completed without removing the cage.After extubation, this was confirmed by ct and it was judged that there was no need for emergency re-operation.No revision surgery has been reported.As no further information about the case was provided, a definite cause cannot be determined.Possible causes include excessive tamping during insertion, improper sizing/trialing/distraction, and/or poor bone quality.If further information is provided in the future, this investigation will be reopened and updated accordingly.
Event or Problem Description
It was reported that during intra-operative placement of a tritanium pl cage, the cage fell anterior to the vertebral body.The surgeon then attempted to remove the cage from behind but could not.The surgery was completed by leaving the cage in place.Revision surgery is not planned at this time but the possibly will be revisited in the future.

• 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: 10984703
• Report Number: 3004024955-2020-00047
• Device Sequence Number: 3019240
• Product Code: MAX
• UDI-Device Identifier: 07613327117523
• UDI-Public: 07613327117523
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181014
• 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): 03/26/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 48951076
• Device Catalogue Number: 48951076
• Device Lot Number: DP9H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/26/2021
• 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: Other