MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 115

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Production process analysis: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: patient #822 index procedure was performed on (b)(6) 2023.On 10-jan-2024 apifix was notified that patient #822 is scheduled for revision surgery on (b)(6) 2024.According to the reporter, "use of the extender lenke 5 lead to an over correction.The extender will be replaced by an apifix screw." on 17-jan-2024 apifix was notified that patient #822 underwent revision surgery on (b)(6) 2024.According to the reporter, "due to the slight progression of the secondary curve and the slight overcorrection of the primary, the extender was removed to maintain the correction and bring the distraction force closer to the midline.Since the patient no longer has any growth potential and does not require additional postoperative correction, the implant was blocked at the end.Surgeon and patient are happy so far." it was further reported that the implantsare not being returned to the manufacturer, according to the reporter, "the implants are property of the patient and hospitals usually only try to convince the patient to dedicate the implants to the industry if the incident was related an implant failure.In this case none of the components failed." curve progression can result from several reasons, such as device misplacement, operating on patients out of the approved indication, implant size selection, extender misalignment, screw misplacement /migration, screw pull-out, implant breakage, infection, ratchet malfunction, and in some cases for no apparent reason.The progression can be either or both of the primary or secondary curve and may also be reported together with pain and or spine imbalance.The risk of curve progression is a known risk.When considering all relevant criteria (curve progression, insufficient curve correction, imbalance) the rate is within the literature reported rate as described in the category "serial casting, deformity progression, crankshaft/adding on, proximal/distal junctional kyphosis, rib prominence, residual rib deformity, trunk imbalance, the distal adding-on phenomenon".The event of insufficient curve correction is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally section.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

Event Description

On 09-jan-2024 apifix was notified that patient #822 is scheduled for revision surgery on (b)(6) 2024.According to the reporter, "use of the  extender lenke 5 lead to an over correction.The extender will be replaced by an apifix screw.".

• Brand Name: MID-C 115
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18639177
• MDR Text Key: 334505028
• Report Number: 3013461531-2024-00002
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: AFS-115-040
• Device Lot Number: AF-11-046-20
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/05/2024
• Date Device Manufactured: 04/19/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Female