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

Model Number MID-C 115

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record confirmed that the device was manufactured and tested according to relevant procedure and shipped according to manufacturer's specifications.On 30-nov-2022 apifix was notified that patient #(b)(6) had a revision surgery performed on (b)(6) 2022 to remove the mid-c following complaints of pain.Patient #(b)(6), index procedure was performed on (b)(6) 2021.Four (4) weeks post-op x-rays demonstrated that the extender kite angle was more than 35° which is not within apifix's described surgical technique."the extender angle should be between 5°-15° degrees compared to the mid-c rod." on (b)(6) 2022, patient #(b)(6) was revised due to device migration resulting in an increase of the kite angle 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." on 30-nov-2022, apifix was notified that the patient came into the clinic on (b)(6) 2022 to see the surgeon about back pains.X-rays were taken which showed migration of the second proximal screw.The implant was removed at (b)(6) the following day on (b)(6) 2022.Surgeons (dr.(b)(6) and dr.(b)(6)) had moved hospitals, hence the different facility, (b)(6).Dr.(b)(6) performed the revision as dr.(b)(6) was sick.All instrumentation was removed as the distal poly screw migrated laterally and there was concern about the screw damaging the lung.During the revision it was confirmed that the lung was not damaged.Apifix clinical affairs identified that during the patient's revision (b)(6), the surgeon replaced the screw at t10 with the same size screw and positioned it in the same place; therefore, there may not have been screw purchase which likely led to the screw migration.The standard of care is to place a larger screw into the same place or reposition the implant as the pedicle might be compromised.Reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r; this complaint does not change the occurrences rate.The event of screw misplacement/migration is addressed in the ifu (dms-4472 rev g) as potential risks associated with the mid-c system and spinal surgery generally at the time of this report, the incident rate for screw misplacement/migration was 2.80% 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%-13%) (cer dms-727 rev u).

Event Description

On 30-nov-2022 apifix was notified that patient #(b)(6) had a revision surgery performed on (b)(6) 2022 to remove the mid-c following complaints of pain.According to the reporter, x-rays were taken which showed migration of the second proximal screw.

Manufacturer Narrative

Return analysis: upon receiving the explanted devices at (b)(6) headquarters ((b)(6), in) the devices were cleaned, sterilized, and evaluated by engineering.Photographs of the device were taken for recording purposes.The [pas] retrieval analysis was not conducted as the device did not meet the criteria of being implanted for more than one year.No defects or damage to the devices were observed.There was no visible wear on the spherical ring of the base.The spherical ring of the pole moved freely.The removal of the device does not appear to be related to the performance of the device.

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16058667
• MDR Text Key: 308392893
• Report Number: 3013461531-2022-00066
• Device Sequence Number: 1
• Product Code: QGP
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2023

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 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 07/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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): Other
• Patient Age: 19 YR
• Patient Sex: Male