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

Model Number MID-C 115

Device Problem Break (1069)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 apifix was notified that patient (b)(6) (pas (b)(6) is scheduled for implant removal on (b)(6) 2024.Reasons for device removal: "curve progression and peri-implant pain and discomfort.".

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, information analysis: patient (b)(6) (pas (b)(6) index procedure was performed on (b)(6) 2021.Patient was seen in clinic on (b)(6) 2023 (earlier than their originally scheduled 2 year f/u in late (b)(6) 2023) for increasing pain & hearing noises around the device.Patient reported 2 concussions with loss of consciousness (1 after fall while doing box jumps, and a second after being hit in the head with a hockey puck).Beginning of noisy symptoms did correlate to sometime after the fall from box jumps.No le numbness, tingling, weakness, or bowel/bladder dysfunction noted.Pi was unable to reproduce noise from the device during the appointment.Ap/lat spine films were taken which showed no change in the appearance of the post-operative spine and no evidence for spinal hardware failure or loosening.Per physician note: "recent increase in back pain, status post recent fall on the back with potential device fracture and mild progression of scoliosis curve.We reviewed exam, images, and treatment options today in office.We reviewed conservative and surgical treatment options.Like to continue with conservative treatment at this time and assess device and scoliosis alignment in roughly 2 months with upright ap/lateral scoliosis radiographs in regular xr machine, not in eos, to help us more definitively assess implant fracture." the patient was scheduled to return for their 2 year visit on (b)(6) 2023.On (b)(6) 2023 apifix followed up with the patient's physician for additional information which was provided.According to the physician, "the patient did return.No obvious implant failure was identified and it was communicated to the family.Nothing concerning was seen and the report of the failure by another doctor was a little premature.The patient still reports noises and creaks, but has been unable to produce them in office.Otherwise, the patient is doing fine.Her spine is stable.".Doctor and family agreed to continue monitoring the patient for another 6 months.On (b)(6) 2024 apifix was notified that patient (b)(6) (pas (b)(6) is scheduled for implant removal on (b)(6) 2024.On (b)(6) 2024 the patient underwent removal surgery.According to the report received, "during the retrieval procedure, while turning the bolt to remove the distal apifix bolt, the distal female part of the device and t11 pedicle screw were removed its entirety.The device was separated during removal with male ratchet coming out of female sleeve indicating ratchet device failure.T11 apifix screw was loose".Reasons for device removal: "curve progression and peri-implant pain and discomfort" "there was black color tissue metallosis surrounding all pedicle screws and apifix device.Tissue sample were collected and will be sent for histopathological analysis.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.Implant breakage is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally.The risk of broken rod - implant breakage has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.The subject device is expected to be returned to manufacturer where a failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.

• Brand Name: MID-C 115
• Type of Device: 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: 19170565
• MDR Text Key: 341359670
• Report Number: 3013461531-2024-00022
• 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: 04/24/2024

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 Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-01-01-19
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 01/23/2019
• 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 Age: 14 YR
• Patient Sex: Female