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

Model Number Template

Device Problem Fracture (1260)

Patient Problem 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 implant was not available to the company;thus, its physical examination was not possible.According to information provided to the company by the surgeon, in order to adjust screw tulip, lateral forces were allied on the screw while it was half way inserted into the pedicle.This resulted in screw breakage.

Event Description

During a surgery with the carboclear pedicle screw system, for the treatment of an oncological patient, a screw was inserted only half way into the l5 pedicle due to patient anatomy and the need to connect to s1 vertebra.When the surgeon tried to adjust the tulip, the screw broke.The screw was removed, and another screw was used.The surgery was successfully completed.

• Brand Name: CARBOCLEAR PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW
• 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: 11021333
• MDR Text Key: 231252106
• Report Number: 9615128-2020-00013
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07290110204372
• UDI-Public: (01)07290110204372(17)240501(10)77214
• Combination Product (y/n): N
• 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: Template
• Device Catalogue Number: PNNS6555
• Device Lot Number: 77214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2019
• 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