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

Model Number MID-C 125

Device Problems Mechanical Problem (1384); Inaccurate Information (4051)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.User (surgeon) information analysis: the correct angle between the extender and apifix rod should be opposite to the curve to prevent a collapse of the implant into the curve.To prevent such cases, apifix took several actions: issued a letter to all surgeons instructing on the rod/extender angle required.Designed a prebent extender to aid in reaching the desired rod/extender angle (eco-48).Implemented a new instrument, "extender-main rod angle measurement" (eco-063), that helps the surgeon adjust the angle between the mid-c main rod and the extender within a range of 5 to 15 degrees.In this case, the surgeon did not use the extender measurement instrument correctly since he has not fully understood the readings on the instrument".(lenke 1 and 5 rather than the actual angle)".Correction: the surgeon had trained and understood how to use the instrument and how to read the scale on it.Risk assessment: at the time of this report (oct 2020), the company's incident rate of extender misalignment is 1.59% which does not increase the probability at the risk assessment.The risk of " extender and mid-c system not properly aligned" has been assessed and found to be acceptable (dms#777 rev q1 hazard id 22.8).The company is closely monitoring eco 63 mitigation effectiveness.

Event Description

The doctor updated the company that the angle between the extender and rod has increased and the lower of the two cranial screws (t11) appears to be drifting.

• 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: 10784164
• MDR Text Key: 214542310
• Report Number: 3013461531-2020-00013
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 10-01-19
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2019
• 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