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

Catalog Number	PNNS5545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved screw was not available to the company, thus it's examination was not possible (and it is difficult to determine the reason for the reported fault).It is noted, though, that several attempts were made to receive the implant, as well as additional details of the case, yet without success.The company did receive a photo of the involved pedicle screw.Based on the photo, the screw indeed broke at the thread.It should be noted, that as indicated in the surgical technique for the carboclear system, tapping of the bone using carboclear bone taps must be performed prior to carboclear pedicle screw insertion.It is unknown whether tapping was performed in the discussed case (although asked, the company did not receive information regarding this issue).Importantly, the pedicle screw was successfully retrieved from the bone.Examination of production records of the involved screw indicated it was manufactured according to specification.In addition, results of mechanical tests performed on sample pedicle screws manufactured during the same period as the involved lot were also according to specification.Note: the company has encountered technical problems to submit a report using webtrader, following certificate renewal; thus the submittance of this report has been delayed.
Event or Problem Description
During a surgery with the carboclear pedicle screw system in (b)(6), for the treatment of oncological patient, a screw broke while being inserted into the pedicle; the screw was successfully removed with a drill.

• 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: 8761995
• Report Number: 9615128-2019-00002
• Device Sequence Number: 1590782
• Product Code: NKB
• UDI-Device Identifier: 17290110200647
• UDI-Public: (01)17290110200647(17)230801(10)75634A
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2019

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: 08/01/2023
• Device Catalogue Number: PNNS5545
• Device Lot Number: 75634A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR