MAUDE Adverse Event Report: APIFIX LTD. MID-C 95; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 95
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
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: patient #559 (pas# (b)(6)) index procedure was performed on (b)(6) 2021.On (b)(6) 2023 apifix was notified that patient #559 (pas# (b)(6)) has a broken implant and is scheduled for revision surgery on (b)(6) 2023.On (b)(6) 2023 the implants were removed.Per the retrieval report, 'the patient was skeletally mature so no device re-implantation was needed.The tissue around t5-t6 was healthy, there was severe, thick metalosis in the t7-t10 region, coating bone, muscle, surrounding implant.Moderate metalosis surrounding the distal apifix screw / bolt / end of device'.The metalosis was classified grade iii.A tissue sample was collected and will be sent for histopathological analysis.It was further reported that there was possible autofusion under the t7-t10 region.  risk assessment: implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism - [implant breakage] has been assessed and found to be acceptable.The implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report.The explanted device is expected to be returned to the manufacturer for analysis.Upon completion of the evaluations, when additional information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
On (b)(6) 2023 apifix was notified that patient #559 (pas# (b)(6)) has a broken implant and is scheduled for revision surgery on (b)(6) 2023.
Additional Manufacturer Narrative
Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was obviously fractured in the pole component around the mid-point of the pole.It appears that post fracture the device remained implanted as the fracture plane, inside of body, and side of pole showed signs of wear.The spherical rings appeared in good condition with minimal wear and some light scratches.Multiple fracture initiation sites were able to be observed despite the fracture surface being partially observed.The suspected failure mode is fatique fracture.No wear analysis was performed as the failure mode was obviously fracture.
Additional Manufacturer Narrative
Follow up 1 was incorrectly submitted for this record.Disregard the text from follow up #1 manufacturer narrative.Follow up 2 (this record) is being submitted to make the correction to health effects impact code.Health effects for this patient - 4627-device explantation.
Additional Manufacturer Narrative
On 05-mar-2024 apifix was notified that patient (b)(6) is planned to undergo revision on (b)(6) 2024 on 06-mar-2024 apifx was notified that patient (b)(6) underwent revision surgery, during which a new mid-c and extender was used & a new apifix screw was placed at l2.One of the off-the-shelf polyaxial screws was removed (t8).The explanted device is expected to be returned to the manufacturer and will be evaluated.Following the evaluation, a supplemental medwatch report will be submitted.

• Brand Name: MID-C 95
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 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.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17963940
• Report Number: 3013461531-2023-00049
• Device Sequence Number: 12668289
• Product Code: QGP
• UDI-Device Identifier: 07290018128015
• UDI-Public: 07290018128015
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: MID-C 95
• Device Catalogue Number: MUS-095-030
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 03/06/2024; 03/06/2024; 03/06/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 03/10/2024; 03/10/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• 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: 16 YR
• Patient Sex: Female