MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

Model Number	P10.7-80C245
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation nor were radiographs or images provided to confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per reporter the nail was not lengthening.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed no external damage to the returned nail.The x-ray images of the internal components showed no damage and revealed the nail has been distracted beyond the midpoint.The nail was functionally tested and was determined to distract and retract using the high-speed magnet tool as well as an external remote controller (erc).The length as received was measured at 291.38 mm.The maximum and minimum lengths were measured at 328.14 mm and 244.75 mm, respectively, giving a total stroke measurement of 83.39 mm which meets the specification.Distraction force testing was then performed and the nail met the specification.The reported failure could not be confirmed as the nail was found to fully functional.Device records review: a review of the device history records (dhr) indicated that the unit met all required quality specifications and testing prior to product departure.

• Brand Name: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
• Common Device Name: FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; aliso viejo, CA 92656
• MDR Report Key: 9758606
• Report Number: 3006179046-2020-00118
• Device Sequence Number: 688356
• Product Code: HSB
• UDI-Device Identifier: 00812258020453
• UDI-Public: 812258020453
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: P10.7-80C245
• Device Lot Number: 8070208AAA
• 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: 02/06/2020
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ERC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 48 KG