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

Model Number MID-C 125

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Discomfort (2330)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

1.First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis from the x-ray image and description, the company deduces that the extender angle progressed over time and that this is the reason for the discomfort the patient felt.2.Risk assessment at the time of this report (oct 25, 2021), the company's incident rate of extender angle progression is (b)(4) this report is the first report done of such risk, the company will continue to monitor this type of event routinely.

Event Description

The company received notification of a planned revision surgery in (b)(6).The revision was performed on (b)(6) 2021 and the following information was received from the distributor: "the patient came to the consultation nine months after surgery, saying that she had discomfort and her back was on the opposite side to the initial one.The doctor discovered that apifix's body had come out too much.- at the revision surgery on (b)(6) 2021, the doctor collected apifix's body, and the patient is now well.".

• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12849775
• MDR Text Key: 282392297
• Report Number: 3013461531-2021-00040
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2021

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 Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 10-01-19
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/20/2021
• Date Device Manufactured: 10/17/2019
• 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): Required Intervention