MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR PEDICLE SCREW SYSTEM; PEDICLE SCREW REMOVAL TOOL

Model Number Extractor

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Examination of the production records of the involved item indicated it was manufactured according to specification.The involved device was not available to the company; thus, its physical examination was not possible.

Event Description

During a surgery with the carboclear pedicle screw system, for the treatment of oncological patient, a screw removal tool broke while trying to remove the distal part of a broken screw.The surgeon used another tool to retrieve the screw and surgery was successfully completed.

• Brand Name: CARBOCLEAR PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW REMOVAL TOOL
• 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: elinor limor ; 11 ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 11021368
• MDR Text Key: 222062677
• Report Number: 9615128-2020-00014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07290110205737
• UDI-Public: (01)07290110205737(10)73319D
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Extractor
• Device Catalogue Number: PPS922940
• Device Lot Number: 73319D
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2019
• 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