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

Model Number	48558528
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During implantation of a screw into the t2 pedicle, the tulip head disengaged.The remaining screw could not be removed and the construct remained in the patient.The surgery had to be terminated at t1 instead of t2 on the right side while the left side was completed successfully.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
It was reported that while implanting a screw, the tulip head popped off.The device was not returned for evaluation but the reported event was confirmed via communication with the sales rep.The surgical technique warns users to insert the screw with the polyaxial screwdriver by placing the hex head socket over the bone screw and threading the end of the outer sleeve into the polyaxial screw head for stable fixation.The locking screwdriver may also be used and attaches to the screw in the same manner as the standard polyaxial screwdriver.Since the lot number was unknown, no manufacturing records could not be reviewed.Conclusion: the plausible root cause of the reported event could not be determined conclusively.However, according to the risk table the screw could have been misaligned for angular insertion into the bone.
Event or Problem Description
During implantation of a screw into the t2 pedicle, the tulip head disengaged.The remaining screw could not be removed and the construct remained in the patient.The surgery had to be terminated at t1 instead of t2 on the right side while the left side was completed successfully.No adverse consequences to the patient were 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: 7632693
• Report Number: 0009617544-2018-00151
• Device Sequence Number: 11249242
• Product Code: NKG
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 08/27/2018

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: 48558528
• Device Catalogue Number: 48558528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR