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

Model Number TYPE 4 ROD

Device Problem Fracture (1260)

Patient Problems Paralysis (1997); Spinal Cord Injury (2432)

Event Date 03/31/2021

Event Type  Injury  

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 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)
• Type of Device: PEDICLE SCREW SYSTEM (ROD)
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; 4672411; herzeliya, ; IS
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; 4672411; herzeliya, ; IS
• Manufacturer Contact: elinor limor ; 11 ha'hoshlim street; 4672411; herzeliya, ; IS
• MDR Report Key: 11744190
• MDR Text Key: 247907670
• Report Number: 9615128-2021-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07290109336367
• UDI-Public: (01)07290109336367(17)250701(10)79321
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2020
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 59 YR