MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL SCREW 9.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48149570
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location is unknown.
Event or Problem Description
A patient reported experiencing pain post-operatively.Imaging showed, "no obvious hardware anomalies," but during revision surgery, the physician identified that the screws were, "obviously loose" and the "head had sheared off" one of the screws.This report captures the second of two screws (loose).
Event or Problem Description
A patient reported experiencing pain post-operatively.Imaging showed, "no obvious hardware anomalies," but during revision surgery, the physician identified that the screws were, "obviously loose" and the "head had sheared off" one of the screws.This report captures the second of two screws (loose).
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW 9.5 X 70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15607081
• Report Number: 0009617544-2022-00093
• Device Sequence Number: 2277649
• Product Code: NKB
• UDI-Device Identifier: 07613327132335
• UDI-Public: 07613327132335
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 48149570
• Device Catalogue Number: 48149570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female