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

Model Number	P10.7-80D245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs 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 in (b)(6) 2019.As per the reporter, the left implant broke two months post index procedure.
Additional Manufacturer Narrative
Additional data: d10, h3, h6.Device evaluation: visual inspection revealed the nail was broken at the top of housing tube right below the second hole, therefore, the reported failure was confirmed.Functional testing and x-ray were not applicable due to the condition of the nail.Based on the information provided, the nail may have broken due to stresses generated by weight bearing prior to full bone consolidation.The device history records were reviewed and no discrepancies were found related to this complaint.The devices were manufactured in accordance with the specified requirements and met all of the required quality inspections.
Event or Problem Description
See updated fields d10/d11: concomitant medical products, h3, h6.

• 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
• MDR Report Key: 10165932
• Report Number: 3006179046-2020-00333
• Device Sequence Number: 19368773
• Product Code: HSB
• UDI-Device Identifier: 00812258020644
• UDI-Public: 812258020644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: P10.7-80D245
• Device Lot Number: A171201-01-01-0AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 15 YR
• Patient Weight: 60