MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 105

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient #225 index procedure was performed on (b)(6) 2018.On (b)(6) 2022 apifix was notified that patient #225 (m.K) had undergone an implant removal surgery.The surgery date and reason for the removal was not provided.The reporter stated that 'there was a lot of suspected metalosis present in patient m.K and some disintegration of the device'.A pathology report for patient m.K revealed that there was no infection.

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 #225 index procedure was performed on (b)(6) 2018.On (b)(6) 2022 apifix was notified that patient #225 (m.K) had undergone an implant removal surgery.The surgery date and reason for the removal was not provided.The reporter stated that 'there was a lot of suspected metalosis present in patient m.K and some disintegration of the device'.A pathology report for patient m.K showed that there was no infection.Despite multiple attempts to obtain additional information, specifically, the reason for the removal and surgery date, no additional information had been provided.For reasons unknown, the implant was removed with no reported patient harm having occurred.Apifix believes that subjecting a patient to another round of anesthesia and additional surgery carries inherent risks, and in an abundance of caution, apifix is reporting this as an adverse event.Should additional information be made available, apifix will file a follow up mdr.

Manufacturer Narrative

The instrument was manufactured to specification; there have been no design changes that would have contributed to this event.Complaint engineering analysis: upon receiving the complaint at orthopediatrics headquarters the packaging was opened and the product reviewed.The implant was in the patient for over four years.There were no fractures observed on the device or obvious reason it was revised.Significant wear was observed on the spherical ring and spherical housing.The wear lines on the spherical ring indicate what is likely repeated back and forth motion as is expected from the normal motion of the device.The wear on the spherical ring housing of the base was significant enough to generate a burr which is beginning to separate from the rest of the device.

• Brand Name: MID-C 105
• 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: 15832667
• MDR Text Key: 308004253
• Report Number: 3013461531-2022-00061
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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 Operator: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-11-05-17
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• 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 Outcome(s): Other
• Patient Sex: Female