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

Model Number	MID-C 125
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
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: patient (b)(6) index procedure was performed on (b)(6) 2022.Patient (b)(6) underwent revision surgery on (b)(6) 2023 due to the initial device reaching maximum elongation; device was replaced with a longer device.(ref: complaint (b)(4) during monitoring, as part of the pas study, apifix identified on (b)(6) 2024 that patient (b)(6) was scheduled for a removal surgery on (b)(6) 2024 due to screw pull-out and subsequent implant migration.According to the report, 'the most distal of the proximal screws has plowed through the pedicle causing increase in the kite angle'.On (b)(6) 2024 apifix identified that patient (b)(6) underwent removal surgery on (b)(6) 2024.No report of patient harm/complications was received.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of screw pullout has been assessed and found to be acceptable the current screw pullout 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 cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.The event of screw pull-out is addressed in the ifu as potential risks associated with the mid-c system.The explanted device is expected to be returned to the manufacturer and will be evaluated; upon its completion, once new information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
During monitoring, as part of the pas study, apifix identified on (b)(6) 2024 that patient (b)(6) (pas (b)(6) was scheduled for a removal surgery on (b)(6) 2024 due to screw pull-out and subsequent implant migration.According to the report, 'the most distal of the proximal screws has plowed through the pedicle causing increase in the kite angle'.
Additional Manufacturer Narrative
Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.During inspection, the device appeared normal with no obvious signs of failure.The extender was removed, and the spherical rings were inspected for wear.No visible wear was found.A marking was found on the implant, which is suspected to be from the cleaning process implant and not indicative of any device failure.

• Brand Name: MID-C 125
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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: 18701639
• Report Number: 3013461531-2024-00010
• Device Sequence Number: 20369452
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/22/2024

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 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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
• Patient Age: 12 YR
• Patient Sex: Female