MAUDE Adverse Event Report: APIFIX LTD MID-C 115; H170001

Model Number	MID-C 115
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Apifix notify on "curve progression in this patient and not understanding the root cause.".
Additional Manufacturer Narrative
Investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.Company investigation based on x-ray and data from the surgeon: the patient's x-rays demonstrate that the lower screw pulled out.A proper pedicle screw chosen by the surgeon (the longest and thickest screw) is common practice in order to gain a superior grip of the screw in the pedicle.Apifix emphasizes optimizing the correct screw size selection during its surgeons training dms 3113 rev i.Per the surgical technical dms-5449 rev g "preoperative planning using x-ray guidance (plain films or ct scan) is important for determining the location of the screws, implant size, and the pedicle screw length and diameter." in the present case, a 6.5x35mm screw was used which was not sufficient and as already seen in the 6 weeks x-ray the screw was pulled out of the t12 vertebra.Risk assessment: the current device screw pulls out rate due to any reason is 2.02% and is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (loss of fixation to bone or connection between implants: (0.4-4.7%) (cer dms-727 rev u).The risk of the screw pull out has been assessed and found to be acceptable (dms#777 rev q1).
Additional Manufacturer Narrative
On 14-nov-2022 apifix was notified that the patient's underwent a revision surgery in which the device was explanted and the patient was revised to fusion; the surgery reportedly 'went extremely smoothly'.

• Brand Name: MID-C 115
• Common Device Name: H170001
• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 14336337
• Report Number: 3013461531-2022-00018
• Device Sequence Number: 6527648
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• 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: 2022
• 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): 11/16/2022

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
• Device Expiration Date: 01/10/2024
• Device Model Number: MID-C 115
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 11/16/2022
• Date Device Manufactured: 01/10/2019
• 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: Required Intervention
• Patient Sex: Unknown