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

Model Number	P8.5-50D215
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned nor has additional information been made available.A root cause is unable to be determined.Journal article citation: vogt, b., rupp, c., gosheger, g., eveslage, m., laufer, a., toporowski, g., roedl, r., & frommer, a.(2023).A clinical and radiological matched-pair analysis of patients treated with the precice and stryde magnetically driven motorized intramedullary lengthening nails.The bone & joint journal, 105-b(1), 88¿96.Https://doi.Org/10.1302/0301-620x.105b1.Bjj-2022-0755.R1.
Event or Problem Description
Information was received that there was dislocation of the nail.No additional information is available.
Additional Manufacturer Narrative
A review of the device history record (dhr) confirmed the device met all required inspections and specifications prior to release.
Event or Problem Description
Additional information has been provided.

• Brand Name: PRECICE SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 16800977
• Report Number: 3006179046-2023-00170
• Device Sequence Number: 19598967
• Product Code: HSB
• UDI-Device Identifier: 00812258020583
• UDI-Public: 812258020583
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P8.5-50D215
• Device Lot Number: A141224-07-00
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Prefer Not To Disclose