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

Model Number MID-C 125

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

Patient #(b)(6) (pas #(b)(6)) index procedure was performed on (b)(6) 2021.On 14-mar-2023, apifix was notified that patient #(b)(6) (pas #(b)(6)) underwent removal of the device on (b)(6) 2023 due to the rod reaching maximum elongation and increased cobb angle.

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) (pas #(b)(6)) index procedure was performed on (b)(6) 2021.On 14-mar-2023, apifix was notified that patient #(b)(6) (pas #(b)(6)) underwent removal of the device on (b)(6) 2023 due to the rod reaching maximum elongation and increased cobb angle.The site reported that they may reinstrument in the future but for now they are going to follow the patient's curve.Clinical affairs review of case information identified that the patient was treated outside of indications, specifically the patient's pre-op primary curve was measured (per pssg: pediatric spine study group) at 63°.The apifix mid-c system is indicated for use in patients having a cobb angle of 35 to 60 degrees.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of curve progression has been assessed and found to be acceptable.The current rate for all relevant criteria (curve progression, insufficient curve correction, imbalance) 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.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.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to engineering evaluation.The device actuated normally.Minimal wear was observed on this spherical rings which did not appear to be through the adlc coating.There were no obvious manufacturing or design defects which contributed to the failure.The wear analysis portion of retreival and analysis protocol was not conducted because the cause of failure was obviously loss of correction and not device related.

• 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 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: 16705235
• MDR Text Key: 312943511
• Report Number: 3013461531-2023-00010
• 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: User Facility
• 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: 04/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-02-004-20
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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