MAUDE Adverse Event Report: APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 125

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 04/13/2023

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: on (b)(6) 2023 apifix was notified that patient (b)(6), index procedure performed on (b)(6) 2022, has a broken implant.Apifix followed up with the surgeon for additional information which was provided.According to the physician "there was no specific trauma to the patient's spine.He (patient) did have a fall on the ice in december but had x-rays after the fall that looked ok.He is a bit of a couch potato.Studying computer programming in college.No sports at all.He's minimally symptomatic.Noticed some "creaking" in his back and came in for an x-ray.He has asked to postpone revision until early may, after his final exams.".Apifix cannot rule out that the fall caused a crack in the device which would not necessarily show up on an x-ray.Implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).The risk for breakage due to the above increases when the implant reaches its maximal elongation.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.Patient was revised on (b)(6) 2023, where the mid-c rod and extender were replaced.The distal apifix screw remained in place.No report of patient harm or complications was received.

Event Description

On (b)(6) 2023 apifix was notified that patient (b)(6), index procedure (b)(6) 2022, has a broken implant.X-ray image was provided.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthogeriatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.Minimal wear was observed on the spherical rings.One location of wear on the ring was adjacent to some wear on the extender, corresponding wear was observed on the fracture surface of the pole.This wear indicates that post-fracture the implant remained implanted.Observation of fracture planes is limited due to the post-fracture wear removing some features for analysis.The two fracture planes are very different in nature, one appears more flat and the other rough and uneven.This suggests two different fracture modes for the two planes, possible a rapid fracture then fatigue, but is not definitive.The wear analysis portion of retrieval and analysis protocol was not conducted because the cause of failure was obvious, implant fracture.

• Brand Name: MID-C 125
• 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 st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16901219
• MDR Text Key: 314895168
• Report Number: 3013461531-2023-00013
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2021
• 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 Age: 19 YR
• Patient Sex: Male