NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Model Number P8.5-80C245 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Ossification (1428); Pain (1994)
|
Event Date 07/13/2018 |
Event Type
Injury
|
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 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.
|
|
Manufacturer Narrative
|
Additional data: a2, a4, b5, d6a, e1 (establishment name), h10.Corrected data: d4, h4.
|
|
Event Description
|
Additional information has been provided.
|
|
Event Description
|
Additional information has been received.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|