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

Model Number	Pedicle Screw - Non Cannulated
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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 involved item was received and underwent an examination.The visual examination (under a microscope) revealed breakage in the middle of the screw shaft.In addition, the screw was cut longitudinally and material integrity was found in order.It is noted, that the discussed case involved post-radiation hard vertebral bone, and that tapping was performed using a 5mm diameter bone tap (prior to 5.5mm diameter screw insertion).
Event or Problem Description
During a surgery with the carboclear pedicle screw system, for the treatment of oncological patient, a screw broke while being inserted into the pedicle; the screw was removed and 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: 10166994
• Report Number: 9615128-2020-00003
• Device Sequence Number: 3636553
• Product Code: NKB
• UDI-Device Identifier: 07290110200640
• UDI-Public: (01)07290110200640(17)240501(10)77210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: Pedicle Screw - Non Cannulated
• Device Catalogue Number: PNNS5545
• Device Lot Number: 77210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR