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

Model Number	MID-C 105
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2002
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 3013461531-2022-00044
• Device Sequence Number: 5895459
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 07/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male