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
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, screw broke and tulip head popped off.There was a surgical delay of 5 minutes.The surgery was completed successfully.No adverse consequences to the patient have been reported.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment result: the reported event was confirmed to have occurred.The screw was disposed of and not available for return.Therefore, the device evaluation could not be performed.Manufacturing records for this product were not reviewed because no lot was provided it was reported that the screw holes were prepared as recommended by surgical technique guide and that the patient had hard bone.Conclusion: the probable root cause is hard bone of the patient.Device was not returned.
Event or Problem Description
It was reported that during procedure, screw broke and tulip head popped off.There was a surgical delay of 5 minutes.The surgery was completed successfully.No adverse consequences to the patient have been reported.

• 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: 8225911
• Report Number: 0009617544-2019-00003
• Device Sequence Number: 19360957
• Product Code: NKG
• UDI-Device Identifier: 04546540596444
• UDI-Public: 04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1