MAUDE Adverse Event Report: APIFIX LTD MID-C 105; POSTERIOR RATCHETING ROD SYSTEM,

Model Number MID-C 105

Device Problem Fracture (1260)

Patient Problem Implant Pain (4561)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

First investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.User (surgeon and patient) information analysis: the x-ray demonstrated screw breakage, usually breakage occurs due to stress concentration at the weakened point on (b)(6) 2022 the patient has a correction surgery to replace the implant due to screw breakage, no metallosis was observed.Design: the design of the mid-c system is aiming to take mainly axial forces, resulting from the load generated by the distraction of the curve and the relevant body weight.The device was tested in an axial direction ((b)(4) rev a) and was found to be able to hold 700n load for 10 million cycles of axial load.Corrective action: in the present case, a standard apifix screw was used.These screws are not in use today as the company shifted to working with lp screws ((b)(4) on 2018) in (b)(6) 2021, the company is adding a radius of 0.1 mm to the thread of all lp pedicle screws.This radius reduces the stress concentrations and reduces the chance of breakage.((b)(4)).Risk assessment: the current screw breakage rate due to any reason is (b)(4) and is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (0.2%-15.5%) ((b)(4) rev u).

Event Description

A revision surgery on (b)(6) 2022 is planned for this patient due to lower screw breakage and pain.The x-ray, demonstrates the breakage of the lower screw.

• 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: 13504030
• MDR Text Key: 289502511
• Report Number: 3013461531-2022-00003
• 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: 02/09/2022

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 Lot Number: AF 07-01-15
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2022
• Initial Date FDA Received: 02/10/2022
• 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