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

Model Number MID-C 125

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notifed that patient # (b)(6) underwent implant removal that day.It was reported that it was a 'scheduled removal', the patient was converted to a fusion, as she wished for further correction (with apifix stilll at a cobb angle of 28 degrees).Patient reported no issues prior to explantation.

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) 2019.Per apifix clinical affairs, the patient curve was 50° with lateral bending of 42°.(patient was treated outside indications for use; "cobb angle of up to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiograph").At 2 years post-op, the patients curve was at 25°.On (b)(6) 2023 apifix was notifed that patient # (b)(6) underwent implant removal that day.It was reported that it was a 'scheduled removal', the patient was converted to a fusion, as she wished for further correction (with apifix stilll at a cob angle of 28 degrees).Reoperation events are a known risk that was assessed and recorded by the product rmf; this complaint does not change the occurrences rate.The risk of inadequate curve correction is a known risk.The risk of misuse- using the system outside the approved indications has been assessed and found to be acceptable in the product rmf.Although no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix device was received, this event resulted in a removal surgery.Apifix believes that subjecting a patient to another round of anesthesia and additional surgery carries inherent risks, and in an abundance of caution, apifix is reporting this event.The explanted device has been returned to the manufacturer and will be evaluated.If following the evaluation, new pertinent information comes to light, then a supplemental medwatch report will be submitted.

Manufacturer Narrative

Device was returned to manufacturer for analysis.Engineering analysis: the explanted device was returned to manufacturer and was subjected to cleaning, steam sterilizing, and engineering evaluation.The reason for removal was [patient] dissatisfaction; the patient wished for further correction (with apifix still at a cob angle of 28 degrees) and was converted to a fusion.During the removal, incidentally, the device was found to be broken.The returned explant was evaluated by engineering and photographed.Minimal wear was observed on the spherical rings, one ring had minor scratches.The device was fractured at first tooth location, at the mid-point of the pole.The fracture plane was photographed.There were no obvious manufacturing or design defects which contributed to the failure.

• 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: 17675636
• MDR Text Key: 322672831
• Report Number: 3013461531-2023-00037
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2023
• 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: AFS-125-050
• Device Lot Number: AF-03-01-19
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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 Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female