MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 45; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811345
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; hardware removal of acdf plate.Three lvl construct.Eight total screws.Allograft spacer in the disk space.The bottom screw at c6 had broken the spring bar on the cervical plate and caused the screw to back out.Surgeon removed that plate and screws in its entirety.The patient doesn't seem to be affected.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment; the plate was confirmed to have a migrated locking mechanism.Manufacturing files were reviewed and no anomalies were found.Potential root causes include: poor surgical candidate or bone quality.Excessive post-op activity by patient (not recommended by surgeon).Patient does not follow surgeon instructions.Patient over exerts.
Event or Problem Description
It was reported that; hardware removal of acdf plate.3 lvl construct.8 total screws.Allograft spacer in the disk space.The bottom screw at c6 had broken the spring bar on the cervical plate and caused the screw to back out.Surgeon removed that plate and screws in its entirety.The patient doesn't seem to be affected.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 45
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7048152
• Report Number: 0009617544-2017-00413
• Device Sequence Number: 1449961
• Product Code: KWQ
• UDI-Device Identifier: 07613252152286
• UDI-Public: (01)07613252152286
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: No Information
• Device Model Number: 48811345
• Device Catalogue Number: 48811345
• Device Lot Number: 169277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 03/08/2018
• 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: 60 YR