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

Model Number	P8.5-80C275
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation nor were x-rays provided to confirm the alleged event.Root cause is unable to be determined at this time.
Event or Problem Description
It was reported that a revision procedure was performed on (b)(6) 2020.It was noticed at a follow up appointment that the nail was no longer lengthening.No patient injury was reported.
Additional Manufacturer Narrative
The customer¿s reported failure mode could not be confirmed.Visual and functional testing observed no anomalies as the nail was found to be meeting specifications.The root cause cannot be determined.A review of dhr indicates for the returned unit confirmed that it met all the required quality inspections (x-ray inspection and acceptance test).

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 10668077
• Report Number: 3006179046-2020-00411
• Device Sequence Number: 2942571
• Product Code: HSB
• UDI-Device Identifier: 00812258020415
• UDI-Public: 812258020415
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: P8.5-80C275
• Device Lot Number: 8022003BAB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: Hospitalization
• Patient Age: 14 YR
• Patient Weight: 45