MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48558524
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulip head of a screw broke off intra operatively after the screw had been placed into the patient.The screw size was 4.5mm x 24mm.
Additional Manufacturer Narrative
(b)(4).Visual inspection; functional inspection; device history review; complaint history review; risk assessment; the product was confirmed visually to have a separated tulip head from repositioning.Manufacturing files were reviewed and no anomalies were found.The probable root cause of the tulip disengagement is not determined.
Event or Problem Description
It was reported that the tulip head of a screw broke off intra operatively after the screw had been placed into the patient.The screw size was 4.5mm x 24mm.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5458129
• Report Number: 0009617544-2016-00078
• Device Sequence Number: 18896172
• Product Code: KWP
• UDI-Device Identifier: 04546540596437
• UDI-Public: 04546540596437
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2016

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: 48558524
• Device Lot Number: 153338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR