MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 105

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

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.Patient: (b)(6) index procedure was performed on (b)(6) 2021.On (b)(6) 2022, patient#: (b)(6) implant was reportedly at full distraction.On 24-may-2022, the distributor contacted apifix, on behalf of the surgeon, for consultation.The surgeon wanted to change the control pin to neutral on patients#: (b)(6) implant because the mid-c was fully extended at the time, and kyphosis increased over time (patient was hunching).Surgeon was asking for advice and tips in performing the 'change to neutral position'.On 26-may-2022, apifix provided a response, "the main concern here of course is the increasing kyphotic posture.Since the scoliotic curve angle is about the same with the initial distraction, we suggest not just moving the control pin to neutral, but to move the control pin to neutral to release some of the distraction and then turn the control pin to the locked position.The locked position is 180 degrees opposite of the ratcheting position (the position it is in now).The neutral position is 90 degrees pointed from where it is now pointed towards the bump.The challenge of course, is that if you are doing this percutaneously, it is possible to access the control pin and turn it to natural.However, there is no way to control how much distraction will actually be released.Perhaps pushing on the rib cage to maintain the correction as much as possible and then allow a gentle release before turning the control pin to the locked position will work.But it is hard to say.Either way, just leaving it in the neutral position is not recommended." on (b)(6) 2022, apifix was notified that the implant had broken.Specifically, the male pole has broken inside the female body most likely due to the excessive motion and forces, bending moments and fatigue with the device being in neutral.The patient is currently awaiting a revision surgery date.The plan is to remove the implant and convert to fusion.Apifix followed up with the distributor for more information.The distributor confirmed that on (b)(6) 2022, during the revision, the surgeon "couldn't release the tension much, and it (the mid-c) was kept at neutral." (per r&d engineering) - the mid-c in neutral position is in its most unconstrained configuration which permits the most unpredictable motion.It appears that the device did offer curve correction until the device was put into neutral; following which the kyphosis was uncontrolled, eventually surpassing our indications.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of broken rod has been assessed and found to be acceptable the current implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.

Event Description

Patient: (b)(6).Index procedure was performed on (b)(6) 2021.  on (b)(6) 2022, patient#: (b)(6) implant was at full distraction.A revision was performed in which the ratchet was moved to neutral position.On (b)(6) apifix was notified that the implant has broken.Specifically, the male pole has broken inside the female body most likely due to the excessive motion and forces, bending moments and fatigue with the device being in neutral.

Manufacturer Narrative

On 29-jan-2023, apifix was notifed that patient #483 underwent removal surgery on (b)(6) 2023.

• Brand Name: MID-C 105
• 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: 15723136
• MDR Text Key: 307602912
• Report Number: 3013461531-2022-00056
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

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
• Device Operator: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-11-05-17
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 01/29/2023
• Supplement Dates FDA Received: 02/09/2023
• Date Device Manufactured: 11/29/2017
• 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 Age: 14 YR