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

Model Number MID-C 105

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/16/2002

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.Patient #(b)(6), pas # (b)(6), index procedure was performed on (b)(6) 2021.X-rays from (b)(6) 2021 (4 weeks post-op) demonstrated that the extender kite angle was at more than 35° which is not within the described surgical technique.Reference dms-5449 rev g2 (surgical technique, page 21, step 26) "the extender angle should be between 5°-15° degrees compared to the mid-c rod." on (b)(6) 2022, during the company's monitoring visit, the following information was captured: "radiograph taken of his spine in pa view shows excellent correction of his spine.However, there is increased angulation between the device and the screws.This is unfortunate position that his implants have migrated significantly.At this point, i do believe we need to move forward with revising his implant in order to reposition it better.This will put less stress on the implant and cause lesser chance of implant breakage".On (b)(6) 2022, the patient was revised due to 'device migration; the kite angle increased since initial implant'.During the revision "the second vertebra screw was removed and upsized to a larger screw.  the 1st vertebra screw remained in place.  the distal screw remained in place.  the original mid-c was explanted and replaced with a new longer mid-c device." post-revision x-rays have not yet been provided.The company's incident rate of extender misalignment is (b)(4).The risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable.

Event Description

Patient #(b)(6) index procedure was performed on (b)(6) 2021.On (b)(6) 2022, the patient was revised due to device migration; the kite angle had increased since initial implant.During the revision, "the second vertebra screw was removed and upsized to a larger screw.The 1st vertebra screw remained in place.The distal screw remained in place.The original mid-c was explanted and replaced with a new longer mid-c device.".

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in (b)(6) and was subjected to cleaning, steam sterilizing, and engineering evaluation.No visible wear was observed on the spherical rings.There were no obvious manufacturing or design defects which contributed to the failure.The wear analysis portion of retrieval and analysis protocol was not conducted because the cause of failure was obviously related to loss of correction.

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15408563
• MDR Text Key: 306210226
• Report Number: 3013461531-2022-00044
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2023

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 Operator: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-02-003-20
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 07/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• 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 Sex: Male