MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 28MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48552428
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw shaft broke during insertion into posterior c2.Used 3.5 tap prior to attempting implantation of screw.Screw shaft was able to be removed using reverse threaded ez out removal tool without incident.
Additional Manufacturer Narrative
Lot# 149619, visual analysis, device history review, complaint history review, risk assessment.The device was confirmed visually to have a fractured shank just below the tulip head.Manufacturing files were reviewed and no anomalies were found.The exact root cause of the tulip disengagement is not determined.
Event or Problem Description
It was reported that the screw shaft broke during insertion into posterior c2.Used 3.5 tap prior to attempting implantation of screw.Screw shaft was able to be removed using reverse threaded ez out removal tool without incident.

• Brand Name: OASYS 4.0 X 28MM POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5978437
• Report Number: 0009617544-2016-00376
• Device Sequence Number: 1665763
• Product Code: KWP
• UDI-Device Identifier: 04546540380678
• UDI-Public: (01)04546540380678
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2016

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: No Information
• Device Catalogue Number: 48552428
• Device Lot Number: 149619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 89