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U.S. Department of Health and Human Services

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

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CARBOFIX ORTHOPEDICS LTD. CARBOCLEAR X PEDICLE SCREW Back to Search Results
Model Number Pedicle Screw - Cannulated
Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
Carboclear x pedicle screw system was used in a revision surgery for the treatment of deformity scoliosis for a metal allergy patient (the original surgery was performed with metal pedicle screw system of another company; carboclear x system or any other implant of carbofix were not used in the first operation). A long construct was involved (t4 - ala). Titanium screws were replaced with carboclear x screws. Due to the length of the rods required, the surgeon used pre-bent titanium rods of another company. During insertion of a carboclear x screw into a low lumbar vertebra, the screw' tulip was disassembled from the screw. No tapping was conducted prior to screw insertion into the vertebra. The disassembled screw was removed. The surgery was completed successfully.
 
Manufacturer Narrative
The case was performed for deformity scoliosis treatment. As stated in the system ifu, the carboclear x system is indicated in the us only for oncological patients. Thus, this was an off-label use; probably due to the fact that the patient was allergic to metal, the surgeon decided to implant cfr-peek pedicle screws. The involved screw was not available to the company; thus, its physical examination was not possible. Nevertheless, examination of production records of the involved pedicle screw indicated that it was manufactured according to specification. The company received photos of the involved screw tulip. It is clear from the photos that the tulip was intact and it had been indeed disassembled from the screw shank. It is noted that this is the first case such an event was reported to the company regarding the carboclear x pedicle screw system. Importantly, it was reported that tapping was not performed prior to screw insertion. As described in the surgical technique for the system, tapping of the bone (using carboclear x bone taps) must be performed prior to carboclear x screw insertion. The absence of tapping and the exertion of excessive torque during screw insertion into the vertebrae (as was reported), probably led to the disassembly of the tulip from the screw. Following disassembly of the tulip, the intact screw shank was extracted using the screw extractor, and the surgery was successfully completed. It is noted, that based on the information provided after the surgery, the company has investigated the event and determined that the case does not need to be reported. The decision not to report was timely documented and justified. Recently the company has received from the fda anonymous reports regarding the case, with some details which are not in line with the information previously provided to the company. The company re-investigated the case and it was concluded that the previous conclusions remain valid. Nevertheless, in order to follow on the anonymous reports and for cautiousness, the company provides this mdr to the fda.
 
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Brand NameCARBOCLEAR X PEDICLE SCREW
Type of DevicePEDICLE 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
hila wachsler-avrahami
11 ha'hoshlim st.
herzeliya, 46724-11
IS   4672411
MDR Report Key14521419
MDR Text Key292793495
Report Number9615128-2022-00003
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07290110209896
UDI-Public(01)07290110209896(17)261001(10)0592
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberPedicle Screw - Cannulated
Device Catalogue NumberPNNSC8550N
Device Lot Number0592
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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