MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 24MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48552424
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon placed pedicle screw in the spine.It was all the way in the bone.Upon disengagement of the screwdriver, the bone screw sheared below the tulip head.The surgeon decided to leave the screw in the patient due to an inability to remove.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the screw tulip was reported to be shipped but was not available for evaluation with the other items in the pi.Manufacturing files were reviewed and no anomalies were found.Conclusion: the probable root cause is the patient's hard bone quality.
Event or Problem Description
It was reported that the surgeon placed pedicle screw in the spine.It was all the way in the bone.Upon disengagement of the screwdriver, the bone screw sheared below the tulip head.The surgeon decided to leave the screw in the patient due to an inability to remove.

• Brand Name: OASYS 4.0 X 24MM 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: 5458179
• Report Number: 0009617544-2016-00080
• Device Sequence Number: 16294021
• Product Code: KWP
• UDI-Device Identifier: 04546540371812
• UDI-Public: 04546540371812
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2016

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: 48552424
• Device Lot Number: 156284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• 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