MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL SCREW 9.5 X 80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48149580

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Pain (1994)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

Device location is unknown.

Event 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 first of two screws (loose, fractured).

Event 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 first of two screws (loose, fractured).

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW 9.5 X 80MM
• Type of Device: 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: 15606988
• MDR Text Key: 301745299
• Report Number: 0009617544-2022-00092
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48149580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female