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

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.

• Brand Name: CARBOCLEAR X PEDICLE SCREW
• Type of Device: PEDICLE 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 Key: 14521419
• MDR Text Key: 292793495
• Report Number: 9615128-2022-00003
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07290110209896
• UDI-Public: (01)07290110209896(17)261001(10)0592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210716
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Pedicle Screw - Cannulated
• Device Catalogue Number: PNNSC8550N
• Device Lot Number: 0592
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1