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

Model Number	P12.5-80D305
Medical Device Problem Codes	Failure to Advance (2524); Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that there was an unspecified implant failure.No additional information is available.
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 precise 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
Additional information was received that there was a problem with distraction.
Additional Manufacturer Narrative
Additional data: b1, b2, b5, d4, h1, h6, h10.

• 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: 16798709
• Report Number: 3006179046-2023-00165
• Device Sequence Number: 15052264
• Product Code: HSB
• UDI-Device Identifier: 00812258020736
• UDI-Public: 812258020736
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P12.5-80D305
• Device Lot Number: UNKNOWN
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose