MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 115

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 08/02/2023

Event Type  malfunction  

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) 2022.On (b)(6) 2023, apifix was notified that patient (b)(6) underwent revision surgery the day prior due to 'loose screw and *max extension'.During the revision the mid-c 115mm rod was replaced with a mid-c 125mm.No report of patient harm/complications was received.Re-operation events are a known risk that was assessed and recorded by the product risk assessment (b)(4).The risk of mechanical failure of the mid-c mechanism resulting in patient re-operation due to inadequate curve correction is a known risk, and has been characterized and documented as acceptable within full risk assessment.The risk of screw pullout (including screw loosening which can lead to screw-pullout) has been assessed and found to be acceptable ((b)(4)) the rate of screw loosening is well within the rate reported in the literature for nut loosening, screw loosening, and screw pull-out, ((b)(4)).Screw loosening can result from infection, improper insertion at the index surgery, osteolysis, or improper screw size selection.Despite follow-ups with the reporter to obtain additional information, no additional information was made available.No product has been returned for evaluation.The root cause could not determined at this time.A review of the device history records confirmed that the device was manufactured and tested according to relevant procedures and shipped according to manufacturer's specifications.If any additional information is provided, a supplemental report will be submitted.*medical device problem code used was: 3191 - appropriate term/code not available.The mid-c system is a ratchet-based self-expandable rod designed to passively increase its length and subsequently maintain its length as the child bends in the corrective direction and also accommodate the natural growth of the spine of young children.In this case the implant (rod) was at its maximum elongation.The appropriate code which isn't available is 'device at maximum elongation'.

Event Description

On 02-aug-2023, apifix was notified that patient (b)(6), index procedure (b)(6) 2022, underwent revision surgery on (b)(6) 2023 due to a loose screw and [implant at] max extension.During the revision the mid-c 115mm rod was replaced with a mid-c 125mm.No report of patient harm/complications was received.

Manufacturer Narrative

Return analysis: the explanted device was returned was subjected to cleaning and steam sterilizing per orthopediatrics work instruction.The explant was evaluated by engineering and photographed.No wear was observed on the spherical rings.The device functioned normally and showed no signs of damage.The wear analysis portion of retrieval and analysis protocol was not conducted because the time of implantation was less than 12 months and the reason for removal was due to screw loosening and exchange due to the device reaching maximum elongation.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.

• Brand Name: MID-C 115
• 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 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: 17659033
• MDR Text Key: 322378534
• Report Number: 3013461531-2023-00033
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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,Company Representative
• 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: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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: 13 YR
• Patient Sex: Female