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

Model Number	LP4.5-PRF4B
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Impaired Healing (2378); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Information was received that upon explant corrosion was discovered on the plate around the male/ female junction and select screw sites.The surgeon also reported delayed union of the regenerate.
Additional 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 or Problem Description
During routine removal of the plate after the lengthening goal had been achieved, corrosion was discovered on the plate used on the left tibia.The corrosion was noted around plate's male/female junction and select screw sites.At the time of the removal, it was also noted that there was a delayed union of the regenerate in the left tibia; however, no osteolysis was found.A low profile static locking plate was implanted to provide extended surgical site stability and preserve new bone length.No patient harm or adverse impact is associated with this event.

• Brand Name: PRECICE PLATING SYSTEM
• Common Device Name: 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: 12899367
• Report Number: 3006179046-2021-00507
• Device Sequence Number: 3947785
• Product Code: KTT
• UDI-Device Identifier: 00887517021366
• UDI-Public: 887517021366
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female