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

Model Number LSC5-050

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  

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.

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.

Manufacturer Narrative

Additional data: a2, a4, b5, d6a, e1 (establishment name), h10.

Event Description

Additional information has been provided.

Event Description

Additional information has been provided.

Manufacturer Narrative

Additional data: b3, d4, d9, h3, h4, h6, h10.Corrected data: b6.Device evaluation: visual inspection of the returned locking screw determined there was no damage to the screw and the screw met specifications.Upon review of the provided x-rays, nuvasive health professional noted there was no abnormal reaction or abnormal bone growth at the area of the implanted screws.It was also noted that the length of implantation has exceeded the recommended amount per the instructions for use (ifu).The reported event was unable to be confirmed as there was no device or clinical problem found.The inspection data for the returned screw has been reviewed and confirms the part met design specifications per the engineering drawings prior to product departure.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 SCREWS
• Type of Device: 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: 15329975
• MDR Text Key: 299006663
• Report Number: 3006179046-2022-00248
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00812258021573
• UDI-Public: 812258021573
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K193617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LSC5-050
• Device Lot Number: 160205-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 80 KG