MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 105
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 02-aug-2023 apifix was notified that patient (b)(6) is scheduled for revision surgery on (b)(6) 2023 due to the patient's mid-c 105 maxing out.No report of patient harm/complications was received.
Additional 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 02-aug-2023 apifix was notified that patient (b)(6) was scheduled for revision surgery on (b)(6) 2023 due to the patient's mid-c 105 maxing out.On (b)(6) 2023 apifix was notified that the revision was performed as planned.No report of patient complications was received.The mid-c 105 was replaced with a mid-c 125, and a new extender was used.The kite angle was checked twice (1st @10°, 2nd @15°).The screws were solidly in bone from the index procedure.It was further reported that the implant was not released from the or and will not be returned to apifix.Clinical affairs review of patient (b)(6)'s index procedure case report identified that the patient was treated out of indications (64° curve, 35° lateral bending) and during the index procedure they tried to put in a larger implant, but were unsuccessfult.('with a strong push we could not achieve 115 on the caliper'.).Clinical affairs review of the patient's case determined that the patient was treated out of indications (64° curve, 35° lateral bending).Indication is "cobb angle of up to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiograph".Reoperation events are a known risk that was assessed and recorded by the product risk assessment (b)(4); this complaint does not change the occurrences rate.(b)(4).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.*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'.

• Brand Name: MID-C 105
• Common Device Name: 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: 17659408
• Report Number: 3013461531-2023-00034
• Device Sequence Number: 6324926
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-01-068-21
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/31/2023
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 YR
• Patient Sex: Female