MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 14MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48552314
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was being removed and tulip ripped off.I have only the tulip and am returning it.The surgical delay was ten minutes while they had to get the screw shank out.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; the screw was confirmed visually to have a separated tulip head.Manufacturing files were reviewed and no anomalies were found.The threaded portion of the screw was not returned, only the tulip was retrieved.The exact root cause of the tulip disengagement is not determined.
Event or Problem Description
It was reported that the screw was being removed and tulip ripped off.I have only the tulip and am returning it.The surgical delay was ten minutes while they had to get the screw shank out.

• Brand Name: OASYS 3.5 X 14MM 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: 6015666
• Report Number: 0009617544-2016-00412
• Device Sequence Number: 13722812
• Product Code: KWP
• UDI-Device Identifier: 04546540371683
• UDI-Public: (01)04546540371683
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2016

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: 48552314
• Device Lot Number: 072737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR