MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48955116
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported revision surgery to explant a migrated tritanium pl cage and a fractured es2 integrated blade screw.The patient reported experiencing pain.This report captures the tritanium pl cage.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed.No relevant manufacturing issues were identified as all units met stryker specifications and no similar complaints were identified.From the tritanium pl surgical technique: the tritanium pl cages are to be used with supplemental fixation that is intended for use in the lumbosacral spine.If pedicle screws were not inserted earlier in the procedure, insert pedicle screws at this point or other appropriate supplemental fixation.Compression of the pedicle screws or interspinous device may be used to create segmental lordosis of the segment fused.Early loosening may result from inadequate initial fixation, latent infection, premature loading of the device or trauma.As it was confirmed that the left s1 screw fractured, the most likely root cause for the tritanium pl cage migration was due to inadequate supplemental fixation due to a compromised fixation structure.
Event or Problem Description
A physician reported revision surgery to explant a migrated tritanium pl cage and a fractured es2 integrated blade screw.The patient reported experiencing pain.This report captures the tritanium pl cage.

• Brand Name: 11MM X 6DEG 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: 9167052
• Report Number: 3004024955-2019-00041
• Device Sequence Number: 16245543
• Product Code: MAX
• UDI-Device Identifier: 07613327118094
• UDI-Public: 07613327118094
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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 Expiration Date: 10/07/2021
• Device Catalogue Number: 48955116
• Device Lot Number: ALP6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 54 YR
• Patient Weight: 86