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

Model Number MID-C 105

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Investigation a review of d:hr of production process demonstrate that mid-c 115 system was manufactured, tested and released according to specification.User (vagelis zisis) reported that the implant mechanism failed thus removal surgery will be done on (b)(6) 2022.Comparison of the patient previous x-rays with the current one provided with the event report identifies ratchet malfunction.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 march 2020, a highlight of the risk associated with practicing high demand sports was added to the mid-c training presentation.The present case the implant lot was pre-eco 13 and 59.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 1.4and 1.6).This event does not increase the probability rating.The current incident rate of ratchet malfunction following mitigations stands at (b)(4).

Event Description

Apifix distributor in (b)(4) reported that on (b)(6) 2022 dr.(b)(6) is planning to perform a removal surgery because of failure of the implant and mechanical noise.

• Brand Name: MID-C 115
• 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: 13566543
• MDR Text Key: 290284621
• Report Number: 3013461531-2022-00004
• 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: 02/20/2022

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: 04/30/2020
• Device Model Number: MID-C 105
• Device Catalogue Number: AF 105
• Device Lot Number: AF 05-01-15
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/21/2022
• Date Device Manufactured: 04/30/2015
• 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 Outcome(s): Required Intervention