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 Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record confirmed that the device was manufactured and tested according to relevant procedure and shipped according to manufacturer's specifications.Patient (b)(6) (g.L) index procedure was performed on (b)(6) 2018.On 24-oct-2022, apifix was notifed that patient #217 underwent an 'elective' removal procedure on (b)(6) 2022.Patient x-rays were provided which show that at two years post index surgery ((b)(6) 2020) the patient's curve was at 5° x-rays from three years post index surgery ((b)(6) 2021) show the patient's curve was maintaining at 5° x-rays from four years post-index surgery ((b)(6) 2022) show the patient's curve was at 6°; curve maintainined at 7° one day post-removal.The doctor is hopeful that the patient will return 2-3 months post-removal to see if the curve progresses in a short time or not.Although no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix device was received, this event involved 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, is reporting this event.

Event Description

Patient (b)(6) (g.L) index procedure was performed on (b)(6) 2018.On 24-oct-2022, apifix was notifed that patient #217 underwent an elective removal procedure on (b)(6) 2022.Apifix received no communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix 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 st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15833148
• MDR Text Key: 307918108
• Report Number: 3013461531-2022-00063
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

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 Operator: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-07-01-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/21/2022
• Date Device Manufactured: 07/12/2007
• 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 Age: 21 YR
• Patient Sex: Female