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

Model Number	MID-C 115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional Manufacturer Narrative
Device was returned to manufacturer for analysis.Engineering analysis: during inspection the device appeared normal with no obvious signs of failure.To check the movement of the ring, the movement of the ring was found to be stuck.Reasonable strength was applied to release the movement, which indicated an issue with the ring's mobility.The friction area was identified as the outside of the ring on the pole, in front of the inside surface of the extender.Disassembly of the device revealed signs of wear on the ring.Reassembly and attempts to reproduce the case using a torque meter were unsuccessful.The spherical rings were inspected after the extender was removed.No wear was found on the spherical rings.Wear was detected on the extender side and the outside housing of the spherical ring on the pole.The device showed signs of wear, particularly on the extender and the outside housing of the spherical ring on the pole.The reason for removal of the device was unrelated to its performance, hence the retrieval and analysis protocol was not conducted.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 as a warning and as potential risks associated with the mid-c system and spinal surgery generally.

• Brand Name: MID-C 115
• 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.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18871938
• Report Number: 3013461531-2024-00011
• Device Sequence Number: 12732307
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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: 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,Followup
• Report Date (Section B): 06/30/2024

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 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2024
• Supplement Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 17 YR
• Patient Sex: Female