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 05/11/2023

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: patient (b)(6) index procedure performed on (b)(6) 2018.Patient was treated within the indications, only two screws were used without an extender.  on (b)(6) 2023, patient (b)(6) implant was removed with no additional intervention.Per apifix marketing, "the correction was successful (less than 25 degrees).And the secondary scoliosis was corrected to a certain extent. after a year the patient gained a lot of weight and the implant was completely open {fully extended}, these two elements reduce its level of durability.Patient held on well for another four years with the implant and now it has broken".Risk assessment: 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.The explanted device is not being returned to manufacture for analysis.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 (b)(6) 2023, patient (b)(6) implant was removed.After implant breakage.

• Brand Name: MID-C 125
• 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: 17078308
• MDR Text Key: 316881212
• Report Number: 3013461531-2023-00019
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-10-01-17
• Date Manufacturer Received: 05/11/2023
• Date Device Manufactured: 06/04/2019
• 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: 17 YR
• Patient Sex: Female