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

Model Number	T10.7-80A375
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays, ultrasound images, or bone quality tests provided to confirm the alleged event.No root cause can be confirmed at this time.It is unknown if patient complied with post-operative physical restrictions.No product returned.
Event or Problem Description
Information was received that a revision procedure was performed.As per reporter, the crown of precice nail was damaged in multiple pieces.
Additional Manufacturer Narrative
The nail was received for visual inspection and functional testing.The reported issue was confirmed.The root cause of was identified as potential patient non-compliance to activity restrictions.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 8971725
• Report Number: 3006179046-2019-00154
• Device Sequence Number: 11390526
• Product Code: HSB
• UDI-Device Identifier: 00812258023904
• UDI-Public: 812258023904
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: T10.7-80A375
• Device Catalogue Number: T10.7-80A375
• Device Lot Number: A170119-36
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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: Required Intervention