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

Model Number MID-C 115

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

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.Over the years, the company already implemented corrective action with the following: ·in (b)(6) 2017, all surgeons received a letter detailing the importance of screw insertion trajectory.The topic is also covered in the company's training presentation.·eco-38, replaced the mid-c 125 that extends by 40 mm to mid-c 125 that extends by 50mm allowing more overlap between the pole and base.·eco-46, a trial tool was added to the surgical tools to aid the surgeon in detecting if access tissue remains below the implant.·in (b)(6) 2020, the topic of practicing severe sports was added to the mid-c training presentation.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 rate.Risk assessment: before the mitigations, the device breakage rate was 4.42%.And post mitigations (including this complaint) it is currently 1.53% which is in line with the rate reported in the literature for this type of complications as described in the company's clinical evaluation report ( 0.2%-15.5%) ( (b)(4) rev r).The risk of the broken rod has been assessed and found to be acceptable ((b)(4) rev q1 hazard id 1.8).

Event Description

The follow-up x-ray demonstrates on implant breakage the patient does not have any pain and is feeling well.

• 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: 11075622
• MDR Text Key: 223717149
• Report Number: 3013461531-2020-00020
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993150
• UDI-Public: 7290014993150
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2020

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 Operator: No Information
• Device Model Number: MID-C 115
• Device Catalogue Number: AF115
• Device Lot Number: AF 05-01-15
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Date Device Manufactured: 04/30/2020
• 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