MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE PLATING SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number LP4.5-PRF4B

Device Problems Corroded (1131); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

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 during removal the plate was noted to have visible signs of corrosion around the screw holes in the distraction rod side of the plate and a slight bend.

Manufacturer Narrative

Evaluation summary: the reported condition of discoloration was confirmed with the device exhibiting discoloration around the screw holes in the plate.The identified discoloration is a previously identified issue and is being investigated under the capa process.The device history record was reviewed and no discrepancies were found.The unit was manufactured in accordance with the specified requirements and met all of the required quality inspection criteria.If any additional information becomes available, a supplemental report will be submitted.

Event Description

It was reported that upon planned removal of the precice plate after lengthening goals were successfully achieved and there was radiographic evidence of quality regenerate bone/consolidation, it was noted the plate had visible signs of corrosion around the screw holes in the distraction rod side of the plate.No adverse patient impact was noted and the surgeon will continue with the planned post-op follow up visits/patient monitoring protocol.It was also reported that the patient had been partially weight-bearing in the late consolidation phase of treatment.No additional information is available.

• Brand Name: PRECICE PLATING SYSTEM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 12497601
• MDR Text Key: 272890256
• Report Number: 3006179046-2021-00465
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00887517021366
• UDI-Public: 887517021366
• Combination Product (y/n): N
• PMA/PMN Number: K192181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP4.5-PRF4B
• Device Lot Number: 0072003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR