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 11/23/2023

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 (b)(6) 2020) underwent revision surgery on (b)(6) 2023 due to a broken implant. according to the reporter, "a (b)(6) 2023 review showed implant was doing well with the mid-c is at its the maximum expansion.However x-rays done in (b)(6) 2023 showed that the mid-c had collapsed.X-ray assessment including bending and traction, surgeon showed that the patient is still flexible and since the patient's family wished to continue with apifix , a revision surgery was done on (b)(6) 2023.Pedicle screws were not changed, only the mid-c 125 and a new lenke 5 extender were changed." on (b)(6) 2023 apifix was notified that the retrieved implant is not being returned to manufacture.According to the reporter, the surgeon is unable to provide the implant; it is unknown where it is.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.Over the years, the company already implemented corrective action with the following: on (b)(6) 2017, all surgeons received a letter detailing the importance of screw insertion trajectory.The topic is also covered in the company's training presentation.Eco 8494 (approved in h170001/s013): a design change in the 105 implants that will increase the pole-base overlap to 6 mm instead of 3.5.Eco-46 (approved in h170001/s002): a trial tool added to the surgical tools to aid the surgeon in detecting if access tissue remains below the implant.On march 2020, the topic of practicing severe sports added to the mid-c training presentation.A precaution about severe sports was included in the ifu approved in h170001.  on october 2020, as part of apifix commitment to continuous improvement, capa #020-01 was initiated to further investigate to prevent and minimize the rate of implant breakage.Apifix is closing this complaint at this time, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If new relevant information is made available, apifix will update the complaint record and file a follow up medwatch report.

Event Description

On 28-nov-2023, apifix was notified that patient #(b)(6) (index procedure (b)(6) 2020) underwent revision surgery on (b)(6) 2023 due to a broken implant.

• Brand Name: MID-C 105
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 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: 18343558
• MDR Text Key: 330706181
• Report Number: 3013461531-2023-00058
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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-11-04-17
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female