MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482678570
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product return clarification: the screw remains implanted; however, the disengaged tulip head has been returned.
Event or Problem Description
It was reported that a serrato medial biased polyaxial screw tulip disengaged intra-operatively.During revision surgery, the screw head came off when the final attempt was made to attach the offset connector to the screw.Since the screw body was firmly fixed, it could not be removed and remains in the patient.
Additional Manufacturer Narrative
Visual inspection: only the tulip of the screw was returned.There was deformation on the locking ring indicating that the tulip disengaged from the shank on that side.The shank was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Excessive torsional force applied to the screw may cause the tulip to disengage as according to the surgical technique.Additionally, it was unknown how the rod was reduced.If the rod is not fully reduced in the tulip before final tightening, this can cause additional force to be applied to final tighten the blocker as additional force is required to also reduce the rod.This excess force may cause the tulip to disengage.
Event or Problem Description
It was reported that a serrato medial biased polyaxial screw tulip disengaged intra-operatively.During revision surgery, the screw head came off when the final attempt was made to attach the offset connector to the screw.Since the screw body was firmly fixed, it could not be removed and remains in the patient.

• Brand Name: 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10185957
• Report Number: 3005525032-2020-00029
• Device Sequence Number: 11517443
• Product Code: NKB
• UDI-Device Identifier: 07613327351316
• UDI-Public: 07613327351316
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482678570
• Device Catalogue Number: 482678570
• Device Lot Number: B95660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other