MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552322
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an oasys polyaxial screw tulip disengaged intra-operatively.The surgeon attempted to pull out the screw at with a screwdriver, but it was too hard to pull out.So, he then used a short rod and tightened it with a blocker and tried to pull it out, but the screw head came off.The surgeon left the fractured shaft in the patient.
Additional Manufacturer Narrative
D3 was corrected from 'stryker spine-france' to 'stryker spine-us'.
Event or Problem Description
It was reported that an oasys polyaxial screw tulip disengaged intra-operatively.The surgeon attempted to pull out the screw at with a screwdriver, but it was too hard to pull out.So, he then used a short rod and tightened it with a blocker and tried to pull it out, but the screw head came off.The surgeon left the fractured shaft in the patient.
Additional Manufacturer Narrative
Visual inspection: only the screw tulip was returned as the shank was left in the patient.The tulip was disengaged from the shank.A small rod fragment and blocker were returned as well.Both can be considered concomitant as there was no issues found with either.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Based on the reported event and the returned device, the most likely root cause is excessive removal force.The screw was implanted for 8 years, tissue and bone ingrowth onto the screw shank may have caused difficulty removing the screw.While having difficulty removing the screw, the surgeon used a rod and blocker to helicopter the screw out.This maneuver most likely applied excessive force to the screw causing the tulip to disengage.
Event or Problem Description
It was reported that an oasys polyaxial screw tulip disengaged intra-operatively.The surgeon attempted to pull out the screw at with a screwdriver, but it was too hard to pull out.So, he then used a short rod and tightened it with a blocker and tried to pull it out, but the screw head came off.The surgeon left the fractured shaft in the patient.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10075560
• Report Number: 0009617544-2020-00071
• Device Sequence Number: 2826765
• Product Code: NKG
• UDI-Device Identifier: 04546540371720
• UDI-Public: 04546540371720
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• 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,Followup
• Report Date (Section B): 08/26/2020

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 Model Number: 48552322
• Device Catalogue Number: 48558524
• Device Lot Number: 122755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 07/30/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/08/2020; 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR