MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	P8.5-80C335
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.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
The nail was implanted on (b)(6)2024.However, the patient¿s leg has not lengthened as expected.The electronic remote controller (erc) function was checked to ensure proper operation.The device was replaced on (b)(6) 2024, to ensure proper operation.The patient was also re-educated on the lengthening process, but no progress was observed.On (b)(6) 2024, the nail was replaced, and the removed nail was tested on the back table using the fast distractor and the nail appeared to function correctly.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
The device was returned for evaluation.It was measured upon receipt at 344.77 mm, which exceeds the original measurement recorded in the dhr at the time of production, indicating that the device had lengthened.Additionally, testing confirmed that the device could lengthen when used with a fast distractor.When placed in the force fixture, the device failed to meet the requirements of force output, producing a maximum force of only 50 lbs.X-ray imaging revealed a fracture in the housing tube near the anti-rotation crown feature.However, it remains unclear whether this fracture occurred during or after implantation.It is also uncertain whether this damage contributed to the device¿s inability to distract or achieve the required force output.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: whitney ginter ; 2560 general armistead avenue; audubon, PA 19403 ; 8582005905
• MDR Report Key: 20918481
• Report Number: 3006179046-2024-00187
• Device Sequence Number: 5056183
• Product Code: HSB
• UDI-Device Identifier: 00812258022426
• UDI-Public: 812258022426
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P8.5-80C335
• Device Lot Number: 3121108AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: Required Intervention
• Patient Sex: Unknown