MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 36; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48558536
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	02/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulip popped off of screw during removal.A locking screw driver was being used.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; tulip was confirmed visually to have separated.Manufacturing records for this product were reviewed and no anomalies were found.The exact root cause is undetermined.
Event or Problem Description
It was reported that the tulip popped off of screw during removal.A locking screw driver was being used.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 36
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6413123
• Report Number: 0009617544-2017-00098
• Device Sequence Number: 16309389
• Product Code: KWP
• UDI-Device Identifier: 04546540596468
• UDI-Public: (01)04546540596468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• 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): 05/23/2017

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: 48558536
• Device Lot Number: 116669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1