MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	LP4.5-MLT4B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined.
Event or Problem Description
Information was received that a follow up nerve release/ fasciotomy procedure was performed on (b)(6) 2020.As per the reporter, the patient developed compartment syndrome.
Event or Problem Description
Additional information was received that an osteotomy revision took place on (b)(6) 2020 to continue lengthening treatment.As of (b)(6) 2021 the desired lengthening goal was achieved, however, the patient developed a valgus deformity.A guided growth implant has been implanted to gradually correct the deformity.
Additional Manufacturer Narrative
Additional data: b5, b6, d9.Corrected data: d6 - initial report indicated an explant date of (b)(6) 2020.Based on the new information provided, the device was not explanted.A supplemental report will be submitted if/when any additional information is provided.

• Brand Name: PRECICE PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11363716
• Report Number: 3006179046-2021-00139
• Device Sequence Number: 4037449
• Product Code: KTT
• UDI-Device Identifier: 00887517021687
• UDI-Public: 887517021687
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: LP4.5-MLT4B
• Device Lot Number: 0071317AAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 09/18/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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: 7 YR
• Patient Weight: 22