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

Model Number	LP4.5-SRF40
Medical Device Problem Codes	Corroded (1131); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
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 the plate was found to have corrosion around the male/female junction.Additionally, it was reported that bridging bone was present and osteolysis and scalloping of the regenerate bone were in close proximity to the corroded plate junction.X-ray images showed a slight bend in the plate.The surgeon believes the corrosion formation may have been assisted by wear debris generated by patient weight-bearing.
Event or Problem Description
Corrected lot number was obtained.
Additional Manufacturer Narrative
Device evaluation: upon return, visual inspection of the plate revealed evidence of discoloration.In addition, osteolysis was visible in the provided x-ray images provided.Per reported failure, functional testing was not applicable.Utilizing external assessments and standard corrosion test methods (salt spray), our investigation has identified mechanically assisted crevice corrosion (macc) as the likely direct cause.The key element has been the mechanical micro-movement within the anti-rotation junction of the stryde devices due to the higher weight bearing potential as a result of a more mobile patient population.We have been able to replicate this in-vitro and have developed the mechanical parameters that drive the clinical variation in corrosion.In-vitro testing has shown a correlation between the load on the telescopic junction of the device and the degree of corrosion, with much less corrosion seen at lower loads.This helps explain why different levels of corrosion between patients as weight bearing protocols vary among surgeons.A root cause analysis was performed and found the risks associated with mechanically assisted crevice corrosion (macc) were not adequately identified and mitigated through the risk management/design control process.Device records review: review of device history records reveal that the rod was visually inspected and functionally tested prior to release.

• 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, suite 100; aliso viejo CA 92656
• MDR Report Key: 12269283
• Report Number: 3006179046-2021-00426
• Device Sequence Number: 17207204
• Product Code: KTT
• UDI-Device Identifier: 00887517021229
• UDI-Public: 887517021229
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LP4.5-SRF40
• Device Lot Number: 0072203AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR