MAUDE Adverse Event Report: STRYKER SPINE-US 13X28X12DEG-11; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48953132
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported a post-operative migration of a tritanium pl cage placed at s1.Revision surgery is not planned and there has been no adverse consequence to the patient.
Event or Problem Description
A physician reported a post-operative migration of a tritanium pl cage placed at s1.Revision surgery is not planned and there has been no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history and complaint history records were reviewed for the provided lot number and no relevant manufacturing issues or 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 right 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.

• Brand Name: 13X28X12DEG-11
• 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: 9079552
• Report Number: 3004024955-2019-00038
• Device Sequence Number: 10867419
• Product Code: MAX
• UDI-Device Identifier: 07613327295832
• UDI-Public: 07613327295832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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 Expiration Date: 05/29/2022
• Device Catalogue Number: 48953132
• Device Lot Number: D53J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR