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

Model Number	P8.5-80C245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994)
Date of Event	07/13/2018
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.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the patient presented with pain and a bump at the distal tibia.X-rays revealed sclerosis and extra bone formation around the female end of the nail.The nail has been explanted.Report 1 of 3.
Additional Manufacturer Narrative
Additional data: a2, a4, b5, d6a, e1 (establishment name), h10.Corrected data: d4, h4.
Event or Problem Description
Additional information has been provided.
Event or Problem Description
Additional information has been received.
Additional Manufacturer Narrative
Additional data: b3, h3, h6, h10.Corrected data: b6, d4 (lot number).Device evaluation: visual inspection of the returned nail revealed no external damage and the nail met specifications.The inspection data was reviewed and confirmed the parts met design specifications per the engineering drawings.The reported failure was determined to not have been related to any manufacturing processes or material failure.Provided x-ray images were reviewed by nuvasive healthcare professional and no device related abnormalities were seen; however, increased cortical radiodensity at the male-female junction of the nail was noted.Review of event information found the nail exceeded the guidelines within the instructions for use (ifu) for length of implantation; it had been implanted for over 5 years instead of the one year specified by the ifu.This length of implantation is considered a likely cause or contributor to the increased cortical radiodensity at the male-female junction of the nail.Device labeling: per the ifu, "the device should be removed after implantation time of no more than one year".Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

• 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: 15329900
• Report Number: 3006179046-2022-00246
• Device Sequence Number: 5288176
• Product Code: HSB
• UDI-Device Identifier: 00812258020408
• UDI-Public: 812258020408
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K191336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: P8.5-80C245
• Device Lot Number: A170322-01-0AA
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 11/17/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/15/2022; 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• 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: 24 YR
• Patient Sex: Male
• Patient Weight: 80 KG