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

Model Number MID-C 125

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

Investigation:.A review of dhr of production process demonstrate that mid-c system was manufactured, tested and released according to specification.User (surgeon and patient) information analysis: ratchet malfunction (resulting in backup of the distraction) can result from physical trauma, practicing high demand sports, and tissue growth inside the ratchet mechanism.Ratchet malfunction may be a coincidental finding and may also be reported together with pain/curve progression/noise.Further investigation will be done once the implant will be available.Risk assesment: reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev q this complaint does not change the occurrences rate.Ratchet malfunction risk was assessed and fount to be acceptable in risk assessment and control for mid-c system' dms-777 rev q1 hazard id 1.4 and 1.6).The current incident rate of device-related adverse events is well within the rate reported in the literature.

Event Description

The patient had an elective surgery on (b)(6) 2021, as the 125 implants reached the end of its way.The surgeon planned to move the system one level up.However during the revision surgery , the ratchet mechanism failed to engage, so that the extension achieved could not be maintained.The implant was replaced with new apifix implant.

• Brand Name: MID-C 125
• Type of Device: 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12954636
• MDR Text Key: 281908565
• Report Number: 3013461531-2021-00041
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2021

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
• Device Expiration Date: 03/27/2024
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 03-01-19
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 12/07/2021
• Date Device Manufactured: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention