MAUDE Adverse Event Report: APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

On 22-nov-2022 apifix received a request form from a (netherlands) distributor notifying of a planned implant removal surgery scheduled for on (b)(6) 2022.No patient indicators nor the reason for the removal was not provided.  on 22-nov-2022 apifix followed up with the surgeon for additional information; specifically the reason for the removal surgery; on (b)(6) 2022 the surgeon responded that the implant was removed that day.Reason for the removal was pain and osteolysis proximal screw.No additional information was provided.The risk of osteolysis is a known risk.(b)(4).The event of osteolysis is addressed in the ifu (dms-4472 rev g) as potential risks associated with the mid-c system and spinal surgery generally section (bone resorption).Apifix followed up with the surgon multiple times in attempts to obtain additional information regarding the circumstances surrounding the reported event.(patient indicator and update whether the removal returned positive results to p.Acnes or other infection); no additional information had been received.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.

Event Description

On 22-nov-2022 apifix received a request form from a (netherlands) distributor, notifying of a planned implant removal surgery scheduled for on (b)(6) 2022.Patient indicators and the reason for the removal was not provided at the time.

Manufacturer Narrative

On 05-dec-2022 apifix followed up with the surgeon for additional information specific to a patient indicator and update whether the removal returned positive results to p.Acnes or other infection.No additional information has been received.On 16-dec-2022 apifix received additional information from the surgeon.Patient's index procedure was performed on (b)(6) 2017 (indentified as patient #117), and the culture tested positive for cutibact acnes.

Manufacturer Narrative

Device was returned to manufacturer for analysis.Engineering analysis: the explanted device was returned and was subjected to cleaning and steam sterilizing.The explant was evaluated by engineering and photographed.The device functioned normally.Gold/bronze colored discoloration of the material was observed on the spherical ring housing of the pole.This region was subjected to sem analysis on hitachi s-3400n scanning electron microscope at (b)(6) university on november 1st, 2023 in order to determine what the source of the discoloration was.To fit the device into the machine, it was cut.The results at different sections showed expected material composition indicating that the upper most adlc layer had come off of the implant and a middle layer of the adlc coating, comprised of crn was exposed.There were no obvious manufacturing or design defects which contributed to the removal.

• Brand Name: MID-C 125
• 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: 16001457
• MDR Text Key: 308258618
• Report Number: 3013461531-2022-00065
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-08-01-16
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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