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

Model Number MID-C 125

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Patient no.(b)(6) (participant in fda post-approval study registry per protocol dms-5528 rev d).Index procedure: operated on (b)(6) 2022 the surgeon reported to paul mraz - senior vice president general manager - scoliosis, that the patient fell while ice skating on the weekend of (b)(6) 2022.Per the surgeon, the patient is a very good ice skater.It was a relatively minor fall in her opinion where she fell to her knees, not all the way to the ice on her bottom or back.Prior to this fall, she had absolutely no pain symptoms.The x-ray below demonstrates breakage of the mid-c rod.

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 patient fell while ice-skating on the weekend of (b)(6) 2022.The patient felt immediate pain in the low back probably this was a contributing factor to the implant breakage.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 (see dms#2896 rev a) and was found to be able to hold 700n load for 10 million cycles of axial load.As part of apifix commitment to continuous improvement, capa #(b)(4) was initiated to further investigate to prevent and minimize the rate of implant breakage.The company investigation indicated that implant breakage can result from trauma, practicing severe sports, development of hyper-kyphosis, inserting the pedicle screws in a wrong trajectory, not working according to the surgical technique, and most commonly from the implant reaching its end of the way.Breakages were evident in 3 main regions, the implant base, the main rod, and the rod's connection to the poly-axial joint.The most common point of failure was the implant rod in implants reaching their maximal elongation.Corrective action: in march 2020, the topic of practicing severe sports was added to the mid-c training presentation.(dms-3113) risk assessment: 2.1.The current device breakage rate due to any reason is 4.51% 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%) ( cer dms-727 rev t).The risk of the broken rod has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.8,1.7).

Manufacturer Narrative

Return analysis: upon receiving the devices at orthopediatrics, the implant was taken to purdue university fort wayne and sem equipment was used to evaluate the fracture site.No major observable wear was noted on the spherical rings.Images captured on the sem equipment at 20x zoom of the fracture site were examined.Two zones were noted investigated more closely.Zone a, all surface textures are what are expected with fatigue fracture.No obvious defects, inclusions, or crack initiation sites noted.Zone b, fracture surfaces consistent with fatigue fracture.No obvious defects, inclusions, or crack propagation sites noted.Opposite side of fractured eyelet with two zones noted and investigated: zone c, fractured surfaces consistent with fatigue fracture.No obvious defects, inclusions, or crack initiation sites noted.Zone d, surfaces consistent with fatigue fracture.Two possible fracture initiation sites noted with arrows.No inclusions or obvious defects were noted.The device failure is likely attributed to fatigue failure, with the fracture site originating within the machined pocket for the welded capture ball.Fatigue fractures usually travel in one direction, but because there are multiple faces that show fatigue failure, two potential situations could have occurred.One is that the device saw fatigue loading that changed vectors over time, which would not be surprising due to the dynamic nature of the device.Another is that there were multiple fracture initiation sites.Neither changes the determination that the cause of failure was likely fatigue.

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 13566552
• MDR Text Key: 290276301
• Report Number: 3013461531-2022-00005
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

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 Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-02-004-20
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention