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 Problem Corroded (1131)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 04/12/2021

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 provided.

Event Description

Information was received that during a routine follow up appointment radiography showed a slight varus bend developing in the plate.The patient completed lengthening, however, they developed varus deformity of the right femur bone.At the time of removal, the deformity was acutely corrected.During the removal procedure a small amount of corrosion was seen at the implant's male/female junction.

Manufacturer Narrative

Device evaluation: upon return, visual inspection of the plate revealed the distraction rod of the plate had incurred discoloration.The reported failure of discoloration has therefore been confirmed.Additionally, the inspection revealed the distraction rod of the plate had a slight bend which has been confirmed in the reported description.At the time of removal, the surgical team suspects the plate bending could be related to abnormally tight hip abductor muscles.It was also noted by the surgery team that the bending was not severe enough to require intervention.Per reported failure functional testing was not applicable and the device met the lengthening goal.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.

Event Description

No additional information was received.

• 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: 12233285
• MDR Text Key: 263865072
• Report Number: 3006179046-2021-00418
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LP4.5-PRF4B
• Device Lot Number: 0070201AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR