MAUDE Adverse Event Report: APIFIX LTD MID-C 105; 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 dhr of the production process demonstrates that mid-c 115 system was manufactured, tested, and released according to specification.Surgeon information analysis: the analysis is based on the surgeon corresponded information, once additional information will be available further investigation will be done.Ratchet malfunction (resulting in a 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.In 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 1.4 and 1.6).This event does not increase the probability rating.The total rate of ratchet malfunction for any reason is 3.3% and post eco- 59 0.7%.The company continues to monitor the effectiveness of the mitigation.

Event Description

A revision surgery is planned for (b)(6) 2022 due to ratchet backup/malfunction and the implant is now shorter than as seen on previous follow-up x-ray.In addition the patient heard a "noise" at some point.

• Brand Name: MID-C 105
• 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: 13692618
• MDR Text Key: 287354861
• Report Number: 3013461531-2022-00007
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2022

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: 07/14/2020
• Device Model Number: MID-C 105
• Device Lot Number: AF -07-01-15
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 03/08/2022
• Date Device Manufactured: 07/14/2015
• 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