MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE DISTAL FEMUR PLATE; BONE PLATE

Model Number	Distal Femur Plate
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The case involved an oncological patient with nonunion and loosening of the plate after two years.Examination of production records of the involved implant indicated it was manufactured according to specification.The implant was not available to the company; thus, its physical examination was not possible.Examination of x-rays taken after the incident, suggest plate shaft' distal end loosened from one screw.According to the literature, complications following treatment with distal femur plates, including nonunion and implant failure are not infrequent.Studies demonstrate nonunion rates of up to 20% and loosening rate of about 2% (1).The risk of such incidents increases in the case of pathological fractures.(1) hoffmann mf et al., clinical outcomes of locked plating of distal femoral fractures in a retrospective cohort.J orthop surg res.2013; 8: 43.
Event or Problem Description
A distal femur plate was implanted (in italy) to treat a pathological fracture (a pf nail and bone graft were also implanted in the same bone).About two years later, x-rays revealed nonunion with disconnection of plate shaft' distal end from one screw.A revision surgery was performed in which the plate was removed and replaced with a medial plate.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 10343589
• Report Number: 9615128-2020-00008
• Device Sequence Number: 825660
• Product Code: HRS
• UDI-Device Identifier: 07290109335292
• UDI-Public: (01)07290109335292(17)210501(10)91140
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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 Expiration Date: 05/01/2021
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFELN1816
• Device Lot Number: 91140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/30/2020
• 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