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

Model Number	P10.7-80B275
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the nail was not expanding and a revision procedure had to be performed.The patient used a wheelchair to ambulate and has no history of trauma or accidents.No additional information has been provided.
Additional Manufacturer Narrative
Device evaluation: the nail was returned for evaluation.A visual inspection revealed a deep scratch on the housing tube.The provided patient x-rays show that the gap between the distraction rod and coupler is significantly smaller in the first x-ray than the gap shown in the second x-ray.This would indicate that it is possible that the nail was retracted.Further examination through in-house x-rays indicated that the device was retracted to the point of compressing the anti-jam washer, however, there no damage noted as a result.Functional testing was conducted and the nail met acceptance criteria.Additionally, distraction was successfully performed using a standard fast distractor and external remote controller (erc).Based on these findings, the failure to distract was unsubstantiated as testing showed that the erc could still distract the nail and exert force.The nail was functioning as intended.
Event or Problem Description
No 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: 18564783
• Report Number: 3006179046-2024-00102
• Device Sequence Number: 8124381
• Product Code: HSB
• UDI-Device Identifier: 00812258020262
• UDI-Public: 812258020262
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: P10.7-80B275
• Device Lot Number: 3110206AAA
• 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: 12/31/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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 Age: 21 YR
• Patient Sex: Female
• Patient Weight: 52 KG