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

Model Number	LP4.5-DRF4B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation in progress.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that one week after explant of the plate, following successful lengthening and mature regenerate bone, the patient experienced a fracture of the right femur that possibly originating from a former plate screw site on the proximal bone segment.However, no issues with the plate were noted.The patient was successfully casted and the cast has been subsequently removed, with the patient walking without assistance.No additional information is available.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned plate revealed no external damage to the unit.Per reported failure functional testing was not applicable.The images provided did not show evidence of proximal femoral fracture as described in the complaint.No failure mode can be confirmed as the plate functioned as intended and meets the specifications.Device records review: review of the device history records indicated that the returned product was visually inspected and functionally tested prior to release.
Event or Problem Description
No additional information was received.

• 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: 12132591
• Report Number: 3006179046-2021-00365
• Device Sequence Number: 19872336
• Product Code: KTT
• UDI-Device Identifier: 00887517021762
• UDI-Public: 887517021762
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: LP4.5-DRF4B
• Device Lot Number: 0070622AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: Other
• Patient Age: 6 YR