MAUDE Adverse Event Report: CARBOFIX ORTHOPEDIS LTD. CARBOCLEAR X PEDICLE SCREW SYSTEM (ROD)

Model Number	TYPE 4 ROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Back pain (4895)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rod breakage in oncological patient with corpectomy due to tumor.Examination of the production records of the involved rods indicated they were manufactured according to specification.It is noted that breakage of rods is known and documented in th literature [1], especially in oncological patients in which fusion is not expected.[1] eldin mmm and ali ama, lumbar transpedicular implant failure: a clinical and surgical challenge and its radiological assessment, asian spine j.2014 june; 8 (3): 281 - 297.
Event or Problem Description
Initially, a surgery with the carboclear x pedicle screw system to treat an oncological 61-year-old patient was performed on (b)(6) 2022, in canada.The crboclear x system was utilized in order to stabilize t5 - t10 vertebrae while t8 was removed and a vbr device was used.On (b)(6) 2025, carbofix was informed by its canadian distributor that while the patient was "working on his car" he noticed pain.Imaging was conducted and revealed a broken rod.A revision surgery was performed on (b)(6) 2025, where the broken rod (carboclear shaped rod type 4: diameter - 6.0mm, length - 285mm) was replaced while expanding the construct with new rods from t4 to t11.Two (2) rods and 4 screws (carboclear x system components) were used.

• Brand Name: CARBOCLEAR X PEDICLE SCREW SYSTEM (ROD)
• Common Device Name: PEDICLE SCREW SYSTEM (ROD)
• Manufacturer (Section D): CARBOFIX ORTHOPEDIS 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: yael rubin ; 11 ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 21456097
• Report Number: 9615128-2025-00001
• Device Sequence Number: 15351374
• Product Code: NKB
• UDI-Device Identifier: 07290109336367
• UDI-Public: (01)07290109336367(17)260701(10)1146
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2026
• Device Model Number: TYPE 4 ROD
• Device Catalogue Number: PNNSR6270
• Device Lot Number: 1146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 107 KG