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

Model Number MID-C 125

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: a review of dhr of production process demonstrate that mid-c 125 system was manufactured, tested and released according to specification.Corrective action: 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.The company took several actions to mitigate ratchet malfunction: eco-13, the ratchet flat spring component was changed to a thicker spring (from 0.15 to 0.25mm).Eco-59, addition of a stopper pin to prevent the pole from dislocating from the base and inherit from the design to prevent the collapse of the ratchet.In (b)(6) 2020, a highlight of the risk associated with practicing high demand sports was added to the mid-c training presentation.The best assumption in similar past cases was that tissue growth into the ratchet mechanism was the reason for the problem.The present cases was done prior to these mitigation's.The current incident rate of ratchet malfunction stands at 1.1%(including the present case).Risk assessment: 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.The risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.1and 1.6).This event does not increase the probability rating.

Event Description

On 29/nov/2021 the distributer sent prof floman requested consultation in regard as the ratchet backed up and the patient hard metallic noise from the 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: 12983528
• MDR Text Key: 286766589
• Report Number: 3013461531-2021-00046
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 12/11/2021

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: 11/26/2019
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-01-14
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/13/2021
• Date Device Manufactured: 11/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention