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	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved screw was not received at our facility.Since we could not examine the item, it was difficult to determine the reason for the reported fault.Nevertheless, examination of the production records of the involved item indicated it was manufactured according to specification.In addition, results of mechanical tests performed on sample pedicle screws manufactured at the same period as the involved lot, were according to specification.In order to simulate the reported case, a torsion test was performed for two 5.5mm diameter carboclear pedicle screws, with results that met carbofix acceptance criteria.The test included pedicle screw insertion into a bone model (rigid polyurethane foam) using a screwdriver and torque meter (no tapping was performed prior to insertion, in order to simulate worst case scenario).
Event or Problem Description
During fixation of t6-t11 vertebrae of oncological patient in (b)(6), one of the screws at t9 was inserted in a manner that the screw tulip touched the pedicle.This caused significant resistance that led to excessive torque and breakage of the screw.The physician decided the construct is strong enough (leaving the screw in situ, with fixation of two levels above and two levels below the affected vertebrae).

• 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: 9556734
• Report Number: 9615128-2020-00001
• Device Sequence Number: 2238056
• Product Code: NKB
• UDI-Device Identifier: 07290110200640
• UDI-Public: (01)07290110200640(17)230701(10)72961A
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 07/01/2023
• Device Model Number: Pedicle Screw - Non Cannulated
• Device Catalogue Number: PNNS5545
• Device Lot Number: 72961A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1