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

Model Number MID-C 115

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/13/2023

Event Type  malfunction  

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) index procedure performed on (b)(6) 2022.During monitoring, as part of the pas study, apifix was made aware on 08-feb-2024 that patient (b)(6) ((b)(4)) reported prominence of instrumentation causing discomfort (noted on 12/29/2023).According to the report, the patient had generalized back pain with pain into both legs (seen on (b)(6) 2023 with c/o generalaized back pain).It was further reported that the pain in legs was before and after procedure (aggravation of a pre-op known condition). schroth physical therapy was attempted that did not give relief; she was then referred to a pain clinic for pain management plan; new pt rx was given on (b)(6) 2023 to concentrate on hips and shoulders that did not offer much relief.On (b)(6) 2024 apifix was notified that patient (b)(6) ((b)(4)) underwent removal surgery on (b)(6) 2024.According to the reporter, "patients bone quality was not great.Surgeon is suspicious of a possible underlying soft tissue disorder." the patient  preop mri findings were: 'abnormal mild neural foraminal narrowing on left at l5-s1; narrowing at recess of l4-5 with possible contact of descending l5 nerve root' prior to removal, the findings were: 'disc bulge at l4-l5 with associated mild right neural foraminal narrowing with no significant spinal canal narrowing. the right transpedicular screw at l4 located immediately superior to the exiting right l4 nerve root. small disc bulge at l5-s1 without significant spinal canal or neural foraminal narrowing.' the risk of pain is a known risk.Pain associated with scoliosis is well described in the literature regardless of having corrective surgery.Pain can also be a transient complaint associated with the surgical procedure or be secondary to device failure, infection/inflammation, curve progression, screw pull-out, loosening, migration, protrusion, and prominence.This risk has been assessed and found to be acceptable.The event of pain 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 device is expected to be returned to manufacturer for evaluation.Following the evaluation a follow up mdr will be submitted.

Event Description

During monitoring, as part of the pas study, apifix was made aware on 08-feb-2024 that patient (b)(6) ((b)(4)), index procedure performed on (b)(6) 2022, reported prominence of instrumentation causing discomfort (noted on 12/29/2023).According to the report, the patient had generalized back pain with pain into both legs (seen on (b)(6) 2023 with c/o generalaized back pain).It was further reported that the pain in legs was before and after procedure (aggravation of a pre-op known condition). schroth physical therapy was attempted that did not give relief; she was then referred to a pain clinic for pain management plan; new pt rx was given on (b)(6) 2023 to concentrate on hips and shoulders that did not offer much relief.On (b)(6) 2024 apifix was notified that patient (b)(6) ((b)(4)) underwent removal surgery on (b)(6) 2024.According to the reporter, "patients bone quality was not great.Surgeon is suspicious of a possible underlying soft tissue disorder.".

• Brand Name: MID-C 115
• Type of Device: 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.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18871938
• MDR Text Key: 337757991
• Report Number: 3013461531-2024-00011
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2024
• 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
• Date Manufacturer Received: 02/08/2024
• 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: 17 YR
• Patient Sex: Female