MAUDE Adverse Event Report: APIFIX LTD MID-C 105; POSTERIOR RATCHETING ROD SYSTEM,,,

Model Number MID-C 105

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

First evaluation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Risk assessment: at the time of this report (march 29, 2021), the company's incident rate of pain (not related to the surgical procedure) is (b)(4) which is well within the rate reported in the literature (cer -clinical evaluation report (b)(4)) the risk of pain is a known risk that has been assessed and found to be acceptable (b)(4).Event of pain addressed in the ifu warnings and precautions section: "metallic implants can loosen, fracture, corrode, migrate, or cause pain".

Event Description

The distributor reported that the patient complained about pain.The surgeon decided to remove the implant.Removal surgery was performed on (b)(6) 2021.

• 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 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: 11648187
• MDR Text Key: 246771591
• Report Number: 3013461531-2021-00017
• 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: distributor,foreign,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/12/2021

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 Operator: No Information
• Device Expiration Date: 11/21/2022
• Device Model Number: MID-C 105
• Device Catalogue Number: AF105L
• Device Lot Number: AF 11-04-17
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/12/2021
• Date Device Manufactured: 11/21/2017
• 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