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

Model Number MID-C 85

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 11/07/2021

Event Type  Injury  

Event Description

The patient follow up x-ray indicates ratchet malfunction as the rod is now shorter compared to the x-ray taken 4 years before.

Manufacturer Narrative

1.Investigation: 1.1a review of dhr of production process demonstrate that mid-c 85 system was manufactured, tested and released according to specification.1.2the best assumption in similar past cases was that tissue growth into the ratchet mechanism was the reason for the problem 2.Corrective action 2.1.The company has implemented corrective action resulting in an updated design of the mid-c to increase the strength of the ratchet spring (eco13 dms-1213) and a design change of the stopper pin (eco-59 dms-5986).2.2.The present cases was done prior to these mitigations.The current incident rate of ratchet malfunction stands at 1.1%(including the present case).3.Risk assessment 3.1.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.3.2.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.4.Patient outcome on (b)(6) 2021 the patient underwent a correction surgery- and a new mid-c system was implanted.

• 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: 12954652
• MDR Text Key: 281872080
• Report Number: 3013461531-2021-00043
• 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: 12/07/2021

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: 09/02/2019
• Device Model Number: MID-C 85
• Device Catalogue Number: AF85
• Device Lot Number: AF 09-01-14
• Initial Date Manufacturer Received: 11/07/2021
• Initial Date FDA Received: 12/07/2021
• Date Device Manufactured: 09/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention