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

Model Number	MID-C 115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional 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: (b)(6) index procedure was performed on (b)(6) 2023 apifix was notified that patient #748 (b)(6) was seen in the clinic on (b)(6) 2023 and x-rays showed that the apifix rod was broken.Patient experienced an acute onset of pain the week prior to being seen in clinic.Surgeon plans to do a revision in (b)(6) 2024 by replacing to a new rod.Risk assessment: implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism - [implant breakage] has been assessed and found to be acceptable.The implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report.The explanted device is expected to be returned to the manufacturer for analysis after the revision surgery.Upon completion of the evaluations, when additional information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
On 05-dec-2023 apifix was notified that patient #748 (b)(6) was seen in the clinic on (b)(6) 2023 and x-rays showed that the apifix rod was broken.Patient experienced an acute onset of pain the week prior to being seen in clinic.Surgeon plans to do a revision in (b)(6) 2024 by replacing to a new rod.
Additional Manufacturer Narrative
On 01-feb-2024 apifix was notified that patient (b)(6) underwent revision surgery on that day, (b)(6) 2024.According to the reporter, there was gray around the area where the rod broke (right where the device distracts).The surgical aite at the time of removal was described as 'metallic debris around the broken area.A tissue sample was collected for analysis.Device is expected to be returned to manufacturer for evaluation.

• Brand Name: MID-C 115
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18434763
• Report Number: 3013461531-2023-00061
• Device Sequence Number: 7780986
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2024

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 115
• Device Catalogue Number: MUS-115-040
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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 Sex: Female