MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48558532
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the tulip head of a 4.5 screw popped off while implanting.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was confirmed visually to have a separated tulip head.Manufacturing files were reviewed and no anomalies were found.The possible root causes include: poor bone quality, user applies too much axial/rotational/cantilever forces, improper hole preparation.
Event or Problem Description
It was reported that; the tulip head of a 4.5 screw popped off while implanting.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6100729
• Report Number: 0009617544-2016-00449
• Device Sequence Number: 1168127
• Product Code: KWP
• UDI-Device Identifier: 04546540596451
• UDI-Public: (01)04546540596451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: 48558532
• Device Lot Number: 163149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR