MAUDE Adverse Event Report: APIFIX LTD MID-C 115; POSTERIOR RATCHETING ROD SYSTEM,

Model Number MID-C 115

Device Problem Biocompatibility (2886)

Patient Problem Implant Pain (4561)

Event Date 09/20/2021

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 patient kyphosis angle pre-op was high within the approved indications and hence the company advised "the kyphosis at t12 may be problematic.Pay extra attention to clean under the implant in this location.Leave the t9 screw higher than the t10 screw.Don't drive the l3 screw too low but leave it 3-4 mm above the bone.Make sure the male pole of the mid-c rod is positioned cephalad.Following the patient 6 month follow-up the surgeon noted the kyphosis was worsening but no patient complaints.X-ray evaluation implies that the failure was caused due to the progression of the kyphosis generating a force below the implant.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)) 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, (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: the company already implemented corrective action of extender left (eco-8696 and supplement s003), in some thoracolumbar cases the surgeon may consider to use the pre-bent extender (extender left) to guarantee full range of motion for the poly-axial joint.Risk assessment: the current device 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)).The risk of the broken rod has been assessed and found to be acceptable ((b)(4) hazard id (b)(4)).

Event Description

The surgeon reported that the mid-c rod broke.

• Brand Name: MID-C 115
• 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: 12672184
• MDR Text Key: 278133403
• Report Number: 3013461531-2021-00033
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2024
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF 05-01-19
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Date Device Manufactured: 05/01/2019
• 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