MAUDE Adverse Event Report: APIFIX LTD MID-C 85; POSTERIOR RATCHETING ROD SYSTEM,,

Model Number MID-C 85L

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

The x-ray demonstrates that the ratchet mechanism has collapsed.The best assumption in similar past cases was that tissue growth into the ratchet mechanism was the reason for the problem.Since the implant is not available for evaluation full investigation and conclusion cannot be determined at this stage.Risk assessment and corrective action: 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.The company has implemented corrective action resulting in an updated design of the mid-c 125 to increase the strength of the ratchet spring (eco13 dms-1213) the incident rate of ratchet malfunction before this mitigation is 3.9% and following this mitigation stands at 1.75%(including the present case).Besides, the company implemented an additional design change of the stopper pin (eco-59).No ratchet failures were reported following this mitigation.The current incident rate of device-related adverse events (6.78% vs 15.5% reported in the literature.See cer dms 727 rev r4).

Event Description

The x-ray indicates on ratchet malfunction.

• Brand Name: MID-C 85
• 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: 10841552
• MDR Text Key: 216334819
• Report Number: 3013461531-2020-00016
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993129
• UDI-Public: 7290014993129
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2020

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 Operator: No Information
• Device Expiration Date: 04/20/2022
• Device Model Number: MID-C 85L
• Device Catalogue Number: AF85L
• Device Lot Number: AF 04-01-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2020
• Date Device Manufactured: 04/20/2017
• 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
• Patient Age: 12.6 YR