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

Model Number	Template
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 11021333
• Report Number: 9615128-2020-00013
• Device Sequence Number: 3814203
• Product Code: NKB
• UDI-Device Identifier: 07290110204372
• UDI-Public: (01)07290110204372(17)240501(10)77214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: Template
• Device Catalogue Number: PNNS6555
• Device Lot Number: 77214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1