MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48558524
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra-op the head of the poly axial screw came out.The broken screw was not retrieved and surgery was completed using new screw.No other adverse consequences was reported to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed upon visual inspection.The head was returned but the bone screw remained implanted as it could not be explanted safely.Manufacturing records were reviewed and no anomalies were found.It was reported that the screw was firmly attached to the driver and that the angle may have been steep.Conclusion: the plausible root cause of the reported event could not be determined conclusively.However, according to the risk table the contributing factors could be : screw could have been misaligned for angular insertion into the bone, hard bone, screw connected too tight to screw driver.
Event or Problem Description
It was reported that intra-op the head of the poly axial screw came out.The broken screw was not retrieved and surgery was completed using new screw.No other adverse consequences was reported to the patient.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8065523
• Report Number: 0009617544-2018-00267
• Device Sequence Number: 1693177
• Product Code: NKG
• UDI-Device Identifier: 04546540596437
• UDI-Public: 04546540596437
• Combination Product (Y/N): N
• 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): 01/04/2019

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: 48558524
• Device Lot Number: 181042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68