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

Model Number	P10.7-50D230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the patient presented with non-union of the osteotomy and lengthening site and severe muscle atrophy.The nail remains implanted.
Additional Manufacturer Narrative
A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
Event or Problem Description
Additional information has been provided.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
The unit was not returned to nuvasive for direct investigation.Evaluation of the provided radiographic pictures showed that the nail and screws were intact and that there was no issue was found with the nail.Based on the obtained information, the left femoral was lengthening without any abnormal radiographic findings.There was also no muscle atrophy visible on the provided x-ray.The reported failure was unable to be confirmed.The unit¿s work order was reviewed and confirmed that the device passed all inspections per the acceptance testing.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 14889870
• Report Number: 3006179046-2022-00226
• Device Sequence Number: 12333060
• Product Code: HSB
• UDI-Device Identifier: 00812258020637
• UDI-Public: 812258020637
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022

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: P10.7-50D230
• Device Lot Number: A170920-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/04/2022; 08/29/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/11/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 56 KG