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

Model Number	LP4.5-SLF40
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is pending.The root cause is unable to be determined at this time.A supplemental report will be provided when the evaluation has been completed.
Event or Problem Description
Information was received that upon removal, the plate was noted to have discoloration and corrosion.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned plate revealed that the distraction rod of the plate had discoloration which confirmed the failure mode.Per the reported failure functional testing was not applicable.The reported failure mode is being investigated for root cause.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 or Problem Description
No additional information was provided.

• 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: 11888504
• Report Number: 3006179046-2021-00287
• Device Sequence Number: 11842812
• Product Code: HTT
• UDI-Device Identifier: 00887517021267
• UDI-Public: 887517021267
• 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): 08/12/2021

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-SLF40
• Device Lot Number: 0071412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR