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 Problem Implant Pain (4561)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Risk assessment: the risk of pain is a known risk that has been assessed and found to be acceptable (dms#777 rev q1).Event of pain addressed in the ifu warnings and precautions section: "metallic implants can loosen, fracture, corrode, migrate, or cause pain".The option of easy implant removal is a benefit for the patient.Post removal the patient looks balanced with good correction maintained.

Event Description

The distributor reported that the patient complained about lumbar pain.The patient asked to remove the implant.

• 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: 11015301
• MDR Text Key: 221725954
• Report Number: 3013461531-2020-00018
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

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: No Information
• Device Expiration Date: 11/01/2021
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-01-16
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/15/2020
• Date Device Manufactured: 11/01/2016
• 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): Required Intervention