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

Catalog Number PRLSN2404

Device Problem Fracture (1260)

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

Event Date 01/18/2015

Event Type  Injury  

Manufacturer Narrative

Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.Examination of the involved device, including under microscope, did not reveal signs of fatigue, and led to the conclusion that the plate broke due to a strong impact.This conclusion is in accordance with the report received by the manufacturer, that the patient fell on his arm, a relatively short period after the operation, i.E., before the fractured bone healed and united.This report is submitted following an fda inspection at the manufacturer facility.

Event Description

On (b)(6) 2015, a piccolo composite dvr plate and a piccolo composite one third tubular plate were implanted in the radius and ulna, respectively, of a (b)(6) patient.After approximately 5 weeks, the patient fell from standing position on out-stretched arm, resulting in breakage of the dvr plate.A second surgery was performed, replacing the dvr plate with another piccolo composite dvr plate, while leaving the 1/3 tubular plate in situ.

• Brand Name: PICCOLO COMPOSITE DVR 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: 6833758
• MDR Text Key: 84096154
• Report Number: 9615128-2017-00007
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• 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: 11/01/2018
• Device Catalogue Number: PRLSN2404
• Device Lot Number: 90287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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: 63 YR