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

Model Number	TYPE 4 ROD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Paralysis (1997); Spinal Cord Injury (2432)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An oncology patient underwent fixation surgery from t12 to s2 vertebrae with l3 and part of l4 vertebrae removed.A fibula bone and a cage were used for anterior support.Imaging of the case were not available to the company at the time of this report.According to the (b)(4) distributor, imaging performed two days after the operation, revealed angling of the fibula strut anteriorly at the proximal end and subsiding of the cage.Four weeks post-operation, during patient extension, the rods broke.Imaging performed after the rods' breakage showed fibula strut angled posteriorly at the anterior end.Examination of the production records of the involved rods indicated they were manufactured according to specification.Examination of the rods themselves did not reveal any deviation from specification.It is the company's conclusion that the use of the fibula bone and cage as anterior support and the migration/subsidence caused an unreasonable load on the rods and as a result led to their breakage.
Event or Problem Description
The carboclear system was implanted in (b)(6) for fixation surgery of an oncological patient (t12-s2).L3 vertebra and part of l4 vertebra were removed due to a tumor.A fibula bone and a cage were used as support along with carbofix system's components (rods, screws, locking elements and transverse connectors).Imaging of the case were not available to the company at the time of this report.According to the (b)(4) distributor, imaging conducted two days post-operation indicated that the fibula strut angled and the cage subsided.Approximately 4 weeks post-operation, while the patient was hoisted out of bed, the two long rods connecting the t12 and s2 vertebrae broke.The cage, fibula bone, screws and rods were removed the following day.A new vbr, pedicle screws and rods were implanted.

• Brand Name: CARBOCLEAR PEDICLE SCREW SYSTEM (ROD)
• Common Device Name: PEDICLE SCREW SYSTEM (ROD)
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; 4672411; herzeliya, ; IS
• MDR Report Key: 11744190
• Report Number: 9615128-2021-00002
• Device Sequence Number: 17193533
• Product Code: NKB
• UDI-Device Identifier: 07290109336367
• UDI-Public: (01)07290109336367(17)250701(10)79321
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 07/01/2025
• Device Model Number: TYPE 4 ROD
• Device Catalogue Number: PNNSR6270
• Device Lot Number: 79321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 59 YR