MAUDE Adverse Event Report: STRYKER SPINE-US TRITANIUM PL CAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	UNK_SPN
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a tritanium pl cage and mantis redux blocker which backed-out approximately six weeks after implantation.The patient reported experiencing leg pain prior to revision.This record captures the tritanium pl cage.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per 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 blocker migrated out of the screw, causing the rod to migrate out, 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 that a patient underwent revision surgery to address a tritanium pl cage and mantis redux blocker which backed-out approximately six weeks after implantation.The patient reported experiencing leg pain prior to revision.This record captures the tritanium pl cage.

• Brand Name: TRITANIUM PL CAGE
• 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: 9211653
• Report Number: 3004024955-2019-00042
• Device Sequence Number: 12914567
• Product Code: MAX
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162262
• 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): 12/16/2019

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 Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/16/2019
• 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: 51 YR
• Patient Weight: 113