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

Model Number P10.7-50D230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 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.

Manufacturer Narrative

A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

Event Description

Additional information has been provided.

Event Description

No additional information has been provided.

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
• Type of Device: 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
• MDR Text Key: 295228575
• Report Number: 3006179046-2022-00226
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258020637
• UDI-Public: 812258020637
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K191336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 56 KG