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

Model Number	MID-C 105
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.On 13-mar-2024 apifix was made aware that patient #(b)(6) (pas#(b)(4)), index procedure (b)(6) 2021, reportedly has a screw which is migrating.'it appears the superior screw is beginning to plow'.  on 16-mar-2024 was made aware that the patient underwent removal surgery.According to the report, the patient who presented for a routine 2.5 year follow up was found to have her superior screw beginning to plow on x-ray.She was asymptomatic.Patient was taken to or and the implant was removed on (b)(6) 2024.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment; this complaint does not change the occurrences rate.At the time of this report, the incident rate for screw misplacement/migration was well within the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (cer).The event of screw misplacement/migration is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally.Screw misplacement at the index surgery may lead to migration, curve progression, or pull-out over time.Since optimal screw placement, in the middle of the pedicle, is a complex task, especially in the upper part of the spine where the pedicles are very small, this problem is mainly related to the surgeon's skills and the patient's anatomy.In addition, screw migration may also result from an infection.The event may be associated with pain.The explanted device was returned to the manufacturer and will undergo an evaluation.Upon completion of the evaluation, when additional information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
On 13-mar-2024 apifix was made aware that patient #(b)(6) (pas# (b)(6)) reportedly has a screw which is migrating.'it appears the superior screw is beginning to plow". .
Additional Manufacturer Narrative
Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.During inspection, the device appeared normal with no obvious signs of failure.The extender was removed, and the spherical rings were inspected for wear.No wear was found.Markings were found on the rod of the implant; it is suspected these are due to the implant removal process.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

• Brand Name: MID-C 105
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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: 19079469
• Report Number: 3013461531-2024-00021
• Device Sequence Number: 12450790
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-07-039-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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 Age: 13 YR
• Patient Sex: Female