MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® SCREWS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number TSA5-065

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received that the upper titanium bone locking screw was bent.The patient heard an audible crunching noise and during follow up x-rays showed the screw had sheared off completely.No patient adverse event was reported.

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

The precice lock screw has not been returned for evaluation.The lot number has not been supplied nor could the information be obtained.This investigation was performed based on a provided x-ray.During review of the provided x-ray image, it was observed that the screw was sheared off completely as indicated in the reported description of the event.A definitive cause could not be determined due to no device return.Based on investigations of previous, similar complaints, the probable cause is excessive bending force placed on the screw as a result of weight bearing activities.

Event Description

No additional information has been provided.

• Brand Name: PRECICE® SCREWS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13952350
• MDR Text Key: 290113333
• Report Number: 3006179046-2022-00162
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258027902
• UDI-Public: 812258027902
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSA5-065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Male