MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE; BONE PLATE

Catalog Number PPHNN3512

Device Problem Fracture (1260)

Patient Problems Fall (1848); Fracture, Arm (2351); Cancer (3262)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

Based on information provided to the manufacturer and the case x-rays, the pathological fracture - for the treatment of which the plate was implanted - healed.A second trauma, due to patient fall from standing position, resulted in additional fracture and plate breakage.Examination of the x-rays revealed that the plate broke at the area of the second bone fracture.Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.This report is submitted following an fda inspection at the manufacturer facility.

Event Description

A piccolo composite proximal humerus plate was implanted to treat a pathological fracture.Approximately 4 months post-implantation, the patient fell.As reported by the physician, x-rays taken indicated that the original pathological fracture healed and that the second trauma caused an additional fracture, below the original one, as well as breakage of the plate.The patient was in chemo/radio therapy sessions, and his arm was put in a brace.About six weeks afterwards the plate was removed.

• Brand Name: PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: hila wachsler-avrahami ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411 ; 9 9511511
• MDR Report Key: 6833760
• MDR Text Key: 84095641
• Report Number: 9615128-2017-00008
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K102597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: PPHNN3512
• Device Lot Number: 90682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR