MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FEMUR INTRAMEDULLARY NAIL

Model Number	P10.7-80D275
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	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a precice nail was unable to be distracted intra-operatively, it was removed and replaced.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: FEMUR INTRAMEDULLARY NAIL
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 22883201
• Report Number: 3006179046-2025-00117
• Device Sequence Number: 21048109
• Product Code: HSB
• UDI-Device Identifier: 00812258020651
• UDI-Public: 00812258020651
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: P10.7-80D275
• Device Lot Number: 4031305
• Was Device Available for Evaluation?: No
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown