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

Catalog Number	PNNS5545
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved screw was not available to the company, thus it's examination was not possible.It is noted, though, that several attempts were made to receive the implant, as well as additional details of the case, yet without success.The company did receive a photo of the involved pedicle screw.Based on the photo, the screw disassembled.The carboclear pedicle screw is provided as an assembly of the screw and the "tulip" (housing of the screw head).In the involved case, the components disassembled, possibly by applying force upon connecting the screw to the screwdriver.It is noted, that reassembling of the screw is feasible during operation.Alternatively, the screw may be removed (e.G., using carboclear extractor) and replaced with another screw (as was conducted in the discussed case).Importantly, the pedicle screw was successfully retrieved from the bone.
Event or Problem Description
During a surgery in (b)(6), a pedicle screw disassembled (the "tulip" disconnected from the screw); the screw was gripped by a plier and removed (unscrewed).

• Brand Name: CARBOCLEAR PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 8761996
• Report Number: 9615128-2019-00003
• Device Sequence Number: 16803705
• Product Code: NKB
• UDI-Device Identifier: 17290110200647
• UDI-Public: (01)17290110200647(17)230801(10)75634A
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: PNNS5545
• Device Lot Number: 75634A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR