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
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE, INC. / NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• MDR Report Key: 13839961
• Report Number: MW5108338
• Device Sequence Number: 4655158
• Product Code: HSB
• UDI-Device Identifier: 00812258020606
• UDI-Public: 812258020606
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2022
• 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; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White