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

Model Number	MID-C 115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, apifix was notified that patient (b)(4) was throwing a football four weeks ago when she started to have low back pain.It was reported that x-rays showed that she fractured her apifix screw at l4.
Additional Manufacturer Narrative
Investigation: 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.Surgeon, x-ray, information analysis: on (b)(6) 2022, apifix was notified that patient (b)(4) was throwing a football four weeks ago when she started to have low back pain.It was reported that x-rays showed that she fractured her apifix screw at l4 additional details, later received on 04-jan-2023, described that "patient (b)(4) was seen in the (b)(6) on (b)(6) 2022 and reported that about a month prior (b)(6) 2022 the patient was throwing a football and started to develop some lower back pain.Patient had been doing well prior to the lower back pain.Because the patient is skeletally mature and there has been improvement to her lumbar curve from the apifix device, the surgeon would like to remove the device.However, a revision may be performed following a discussion with the patient and patient's family regarding treatment.The revision would involve replacing a damaged screw.The surgery is scheduled for (b)(6) 2023." on (b)(6) 2023 the patient underwent a revision procedure, during which the broken screw was replaced, along with a shorter mid-c & a new extender.  risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of the screw breakage has been assessed and found to be acceptable.This event does not increase the probability rating.The total rate of ratchet malfunction for any reason is 0.80% the risk of screw breakage has been quantified, characterized, and documented as acceptable within full risk assessment.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 will be filed.
Additional Manufacturer Narrative
Return analysis: the explanted device was returned to orthopediatrics in (b)(6) and was subjected to engineering evaluation.The pedicle screw was fractured.Examination under microscope showed beach marks, indicative of fatigue fracture.The fracture initiation site is suspected to be at the base of the thread.The wear analysis portion of retrieval and analysis protocol was not conducted because the time of implantation was less than 12 months and the cause of failure was obvious, pedicle screw fracture.

• Brand Name: MID-C 115
• 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: 16239019
• Report Number: 3013461531-2022-00076
• Device Sequence Number: 6623074
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-05-01-19
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 07/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• 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 Age: 20 YR
• Patient Sex: Female