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

Model Number MID-C 125

Device Problem Migration (4003)

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

Event Date 01/17/2024

Event Type  malfunction  

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 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'.

• Brand Name: MID-C 125
• Type of Device: 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
• MDR Text Key: 335406104
• Report Number: 3013461531-2024-00010
• Device Sequence Number: 1
• Product Code: QGP
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2021
• 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 Age: 12 YR
• Patient Sex: Female