MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482678580
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulip of screw dissociated while placing blocker.A surgical delay of 8 minute was reported to replace the screw.All broken fragments were retrieved.The surgery was completed using the same blocker.No other consequence was reported to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, and risk assessment performed.Functional inspection could not be performed because the device was confirmed to be damaged during visual inspection, and dimensional inspection was not performed because there is no indication the event was related to dimensions of the device.Results: the screw was returned in 2 pieces with the tulip head disengaged from the main shaft.There was deformation on one side of the tulip head, and the rod indentation on the screw shank bulb was at one side and at an angle, indicating that the tulip was over-angulated in one direction.No material or manufacturing defects were identified, and all units met stryker specifications.No similar complaints for the reported lot number were identified.Conclusion: based on the markings noted on the returned screw, the screw was most likely over-angulated in one direction.This can happen if the rod is not fully seated into the tulip and then the blocker is attempted to be inserted, if off axis loading is applied to the screw, and/or if excess torque is applied to the blocker during insertion.Per the surgical technique: extra caution is advised in the following cases: the rod is not horizontally placed into the screw head.The rod is high in the screw head.An acute convex or concave bend is contoured into the rod.
Event or Problem Description
It was reported that the tulip of screw dissociated while placing blocker.A surgical delay of 8 minute was reported to replace the screw.All broken fragments were retrieved.The surgery was completed using the same blocker.No other consequence was reported to the patient.

• Brand Name: 8.5X80 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: 8385948
• Report Number: 3005525032-2019-00004
• Device Sequence Number: 420840
• Product Code: NKB
• UDI-Device Identifier: 07613327351873
• UDI-Public: 07613327351873
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• 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): 05/10/2019

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: 482678580
• Device Lot Number: B73751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1