MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE ONE THIRD TUBULAR PLATE; BONE PLATE

Catalog Number POTTN2011

Device Problems Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

The patient's ulna bone was initially treated in (b)(6) 2016 using two carbofix one third tubular plates.Apperantly, the surgeon decided to extend one of the plates by connecting it to an additional plate.The two plates were implanted as a single construct and connected by screws inserted through overlapping one or two holes of both plates.Six years post-operation, in 2022 (exact date is unknown), a revision surgery was performed at a different medical center due to non-union.The carbofix plates were removed and replaced with a spanning plate.

Manufacturer Narrative

The company found out about the case from a message posted on the social network.Following the message, a company representative contacted the surgeon for more details on the case.According to the information received, the company was able to locate the lot numbers of the involved plates.The plates were not available for physical examination.Nevertheless, examination of the manufacturing records of the involved plates indicated they were manufactured according to specification.The company came to a conclusion that it was an improper usage of the plates (i.E.Two plates were implanted as a single construct and connected through overlapping holes).Since the involved plates were implanted as a single construct, the company is sumbiting a single report.The details of the second involved plate: catalog #: pottn2006, lot #: 90744, expiration date: 31-jul-2020, device manufacture date: 31-aug-2015.

• Brand Name: PICCOLO COMPOSITE ONE THIRD TUBULAR PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11, ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11, ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: alexandra vikanova ; 11, ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 15967216
• MDR Text Key: 305339230
• Report Number: 9615128-2022-00005
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: POTTN2011
• Device Lot Number: 90545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• 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: 48 YR
• Patient Sex: Male