MAUDE Adverse Event Report: APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Production process analysis: 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.User (surgeon and patient) information analysis: on (b)(6) 2024 apifix was notified that a surgery was conducted on patient #(b)(6) on (b)(6) 2024.According to the reporter, the patient had a visit conducted on (b)(6) 2024 where the patient stated there was previous swelling over the incision with some recent fevers but all of it was resolved and denied any back pain.Surgeon noted that the patient's family was to monitor for any erythema, pain, or increased swelling/drainage and to have a follow up visit in 5-6 weeks.After communication between the family and his team noting a returned fever, surgery was scheduled for (b)(6) to do exploratory surgery for any possible infection, and on (b)(6) they discovered it was a deep wound infection which required them to remove the hardware.Implant removed on (b)(6) 2024.On 30-nov-2024 additional information was received."the bacteria that was identified was cutibacterium acnes, " c.Acnes.Risk assessment: late-onset infection is a known risk which was assessed and recorded by the product risk assessment.This complaint does not change the occurrences rate.The event of late infection is addressed in the ifu (dms-4472 rev g) as a warning and as potential risks associated with the mid-c system and spinal surgery generally.The explanted device was returned to the manufacturer and will be evaluated.Following the evaluation, if new pertinent information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
On (b)(6) 2024 apifix was notified that a surgery was conducted on patient (b)(6) on (b)(6) 2024.According to the reporter, the patient had a visit conducted on (b)(6) 2024 where the patient stated there was previous swelling over the incision with some recent fevers but all of it was resolved and patient denied any back pain.Surgeon noted that the patient's family was to monitor for any erythema, pain, or increased swelling/drainage and to have a follow up visit in 5-6 weeks.After communication between the family and his team noting a returned fever, surgery was scheduled for (b)(6) to do exploratory surgery for any possible infection, and on (b)(6) they discovered it was a deep wound infection which required them to remove the hardware.Implant removed on (b)(6) 2024.

• Brand Name: MID-C 125
• 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 st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 20817071
• Report Number: 3013461531-2024-00059
• Device Sequence Number: 8716371
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 05/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Female