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

Model Number MID-C 125

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

Patient #352 index procedure was performed on (b)(6) 2019 on (b)(6) 2022 apifix was notified that patient #352 (b.A) is planned for a removal surgery.The planned surgery date and reason for the removal was not provided.

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 #(b)(6) index procedure was performed on (b)(6) 2019.On 25-oct-2022 apifix was notified that patient #(b)(6) (b.A.) is planned for a removal surgery.The surgery date and reason for the removal was not provided.Despite multiple attempts to obtain additional information, specifically, the date of and reason for the removal surgery, no additional information had been provided.Although no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix device was received, this event is leading to a removal surgery.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

On 20-dec-2022 apifix was notified that the patient underwent removal surgery on that day.No report of patient harm/complication was received.

• 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: 15860254
• MDR Text Key: 307996674
• Report Number: 3013461531-2022-00062
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2023

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 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-03-01-19
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/01/2023
• Date Device Manufactured: 12/04/2018
• 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