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

Model Number P8.5-50M165

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unable to be determined at this time.

Event Description

Information was received that an antegrade nail was put in retrograde and it was noticed during a follow up x-ray that the nail was not working properly.As a result a revision procedure was performed and a new nail was implanted.It was noted the new nail is working as intended.

• Brand Name: PRECICE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 11457763
• MDR Text Key: 239103744
• Report Number: 3006179046-2021-00187
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258028237
• UDI-Public: 812258028237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P8.5-50M165
• Device Lot Number: 0092104AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• 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 Age: 8 YR
• Patient Weight: 20