MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48558528
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, head of poly axial screw popped off.The surgery was completed successfully with no surgical delay or adverse consequences to the patient.
Additional Manufacturer Narrative
Method: labelling review and risk assessment.Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.It was reported that while implanting a screw, the tulip head popped off; the screw was firmly attached to the driver and the angle was not steep.The screw is not available for return.Manufacturing records were not reviewed because a valid lot number was not provided.The plausible root cause of the reported event could not be determined conclusively.Device was misplaced.
Event or Problem Description
It was reported that during the procedure, head of poly axial screw popped off.The surgery was completed successfully with no surgical delay or adverse consequences to the patient.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8409953
• Report Number: 0009617544-2019-00022
• Device Sequence Number: 1288497
• Product Code: NKG
• UDI-Device Identifier: 04546540596444
• UDI-Public: 04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• 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): 05/30/2019

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: Health Professional
• Device Catalogue Number: 48558528
• Device Lot Number: 121212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1