MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X60 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482619560
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw went "inward too much" and neurological symptoms appeared, resulting in revision surgery.
Event or Problem Description
It was reported that the screw went "inward too much" and neurological symptoms appeared, resulting in revision surgery.
Additional Manufacturer Narrative
Correction: hospital declined to return the device for evaluation.Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.The device was implanted concomitantly with a non-stryker rod and offset connector.It is unknown the angle of the screw, how the screw holes were prepped, and what instrument was used to insert the screw.No x -rays or notes were provided.Based on information provided, there is not enough information to determine why the screw migrated inward.From the ifu: "because different manufacturers employ different materials, varying tolerances and manufacturing specifications, and differing design parameters, components of the system should not be used in conjunction with components from any other manufacturer¿s spinal system.Any such use will negate the responsibility of stryker spine for the performance of the resulting mixed component implant.".

• Brand Name: 9.5X60 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8561769
• Report Number: 3005525032-2019-00034
• Device Sequence Number: 2191411
• Product Code: NKB
• UDI-Device Identifier: 07613327352320
• UDI-Public: 07613327352320
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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 Catalogue Number: 482619560
• Device Lot Number: B83440
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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: Required Intervention