MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 24MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	48552324
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the plate screw was implanted at left c2 and advanced more with screw driver, the screw was not advanced and the screw head was slipped.Therefore, the screw was changed the new same other one and the operation was continued.Reportedly; the patient bony substance was heavy and the thread was cutting with tap, but the thread was shallow.The screw thread has broken.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment; the device was confirmed deformed on visual examination.Manufacturing records for this product were reviewed and no anomalies were found.The probable root cause is the patient's bone quality.
Event or Problem Description
It was reported that; when the plate screw was implanted at left c2 and advanced more with screw driver, the screw was not advanced and the screw head was slipped.Therefore, the screw was changed the new same other one and the operation was continued.Reportedly; the patient bony substance was heavy and the thread was cutting with tap, but the thread was shallow.The screw thread has broken.

• Brand Name: OASYS 3.5 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: 6537199
• Report Number: 0009617544-2017-00183
• Device Sequence Number: 10785702
• Product Code: KWP
• UDI-Device Identifier: 04546540371737
• UDI-Public: (01)04546540371737
• Combination Product (Y/N): N
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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 Model Number: 48552324
• Device Catalogue Number: 48552324
• Device Lot Number: 134077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR