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

Model Number	MID-C 115
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient #(b)(6) index procedure was performed on (b)(6) 2022.At the patient's one month follow up, it was identified that the screw at l4 had migrated into the canal.On (b)(6) 2022 the patient was revised to apifix placing a new screw at l3.No sequelae reported.
Additional Manufacturer Narrative
A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Patient #(b)(6) index procedure was performed on (b)(6) 2022.At the patient's one-month follow up, the doctor identified that the screw at l4 had migrated into the canal.On (b)(6) 2022 the patient was revised.The surgeon tried to remove the screw and worked to re-direct it.After some effort the pedicle did in fact break, so it was decided to go up to l3.After the scew relocation, it was found that the mid-c 115 was too big so it was replaced with a mid-c 105.The surgeon believes it was possible that the screw may have migrated during distraction.Risk assessment: at the time of this report, the incident rate for screw misplacement/migration was well within the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (cer).
Additional Manufacturer Narrative
Return analysis: the explanted device was returned to orthopediatrics in (b)(6) and was subjected to engineering evaluation.The device actuated normally.No observable wear was seen on the spherical rings.Some damage was observed on the body and pole, presumably this occurred during or after the removal procedure and not associated with the complaint.There were no obvious manufacturing or design defects which contributed to the failure.The wear analysis portion of retrieval and analysis protocol was not conducted because the time of implantation was less than 12 months and the cause of failure was obvious, pedicle fracture.

• 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.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15353507
• Report Number: 3013461531-2022-00042
• Device Sequence Number: 6049303
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2022
• 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): 07/16/2023

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 Model Number: MID-C 115
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-11-060-20
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 09/03/2022
• Supplement Report FDA Received Date: 07/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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: 14 YR
• Patient Sex: Female