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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

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 upon explant corrosion was discovered on the plate around the male/female junction and select screw sites.No patient adverse event was reported.

Manufacturer Narrative

Device evaluation: upon return, visual inspection of the plate revealed the distraction rod of the plate had discoloration.Utilizing external assessments and standard corrosion test methods, investigation of similar devices has identified mechanically assisted crevice corrosion (macc) based on mechanical micro-movement within the anti-rotation junction of the device as the likely direct cause.In-vitro testing has shown an increased load on the telescopic junction of the device may contribute to macc.Device records review: review of the device history records indicated that the returned product was visually inspected, functionally tested, and passed all quality inspections prior to release.

Event Description

During routine removal of the plate after the lengthening goal had been achieved, corrosion was discovered on the plate used on the right tibia.The corrosion was noted around plate's male/female junction and select screw sites.No patient harm or adverse outcome is associated with this event.

• 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, 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: 12899292
• MDR Text Key: 282013609
• Report Number: 3006179046-2021-00508
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00887517021366
• UDI-Public: 887517021366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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: 0072405AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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 Age: 24 YR
• Patient Sex: Female