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

Model Number	MID-C 105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient (b)(6) index procedure was performed on (b)(6) 2021.On 17-jul-2024 apifix was notified that patient (b)(6) has a broken rod.It is unsure at this time when a revision is planned for or what they plan to do.
Additional Manufacturer Narrative
Investigation: 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.Surgeon, information analysis: on 17-jul-2024 apifix was notified that patient(b)(6), index procedure (b)(6) 2021, has a broken rod.It is unsure at this time when a revision is planned for or what they plan to do.Reoperation events are a known risk that was assessed and recorded by the product risk assessment.Implant breakage is addressed in the ifu (dms-4472 rev g, dms-766 rev u) as potential risks associated with the mid-c system and spinal surgery generally.The risk of broken rod: implant breakage has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.Apifix has not received additional information regarding this case.Once additional relevant details become available; a supplemental mdr will be submitted.
Additional Manufacturer Narrative
On 05-sep-2024 apifix was notified that patient #581 underwent revision surgery during which the rod, extender, and screws were replaced with new ones.No report of patient harm or complication was received.Explanted device is not expected to be returned to the manufacturer.Should additional information be made available, apifix will file a follow up mdr.

• 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: 19981189
• Report Number: 3013461531-2024-00034
• Device Sequence Number: 8141534
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-07-039-20
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 02/12/2020
• 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
• Patient Age: 14 YR
• Patient Sex: Female