MAUDE Adverse Event Report: STRYKER SPINE-US 7.0X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482617050
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw was found to be loose.The patient was in pain and revision surgery was performed for replacement of hardware, upsize screws and fuse posterior lateral.
Additional Manufacturer Narrative
Visual inspection: the returned screw was inspected and no damage or deformation was observed.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Dimensional inspection: not performed because there is no indication the event was related to dimensions of the device.Materials analysis: not performed because there is no indication the event was related to materials properties.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed via x-ray that a screw main body migrated post-operatively.Based on the information received, it was difficult to confirm the number of screws reported to have migrated; conservatively, we deem all reported screws under this event migrated.The root cause for screw migration is due to the unstable construct of the supplemental fixation system secondary to the blocker migration.
Event or Problem Description
It was reported that the screw was found to be loose.The patient was in pain and revision surgery was performed for replacement of hardware, upsize screws and fuse posterior lateral.

• Brand Name: 7.0X50 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8467186
• Report Number: 3005525032-2019-00025
• Device Sequence Number: 19200401
• Product Code: NKB
• UDI-Device Identifier: 07613327351507
• UDI-Public: 07613327351507
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 482617050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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