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

Model Number P8.5-80D245

Device Problem Defective Component (2292)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2022

Event Type  Injury  

Event Description

The patient has a history of a limb length discrepancy that has been treated with a lengthening rod in the past.A lengthening rod was recently placed on (b)(6) 2022 and the rod itself was found to be malfunctioning.Options were discussed and because it had been a couple of weeks, it was decided to remove and exchange the rod and also make sure that the osteotomy was complete, so the leg would be appropriately lengthened.The defective rod was removed and replaced on (b)(6) 2022.Fda safety report id # (b)(4).

• Brand Name: PRECICE FEMORAL LIMB LENGTHENING SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE, INC. / NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• MDR Report Key: 13839961
• MDR Text Key: 287604337
• Report Number: MW5108338
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 812258020606
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: P8.5-80D245
• Device Lot Number: 1082306AAA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White