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

Model Number MID-C 105L

Device Problems Degraded (1153); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.User (surgeon) information analysis: once the implant will be available for investigation full evaluation will be done to understand the cause.Risk assessment: the company's vigilance activities demonstrate that mid-c system mechanical noise is usually secondary to a malfunction of the device ratchet, breakage or components come to loosen and rarely as a standalone complaint.In the present report, the noise was reported with occasional pain, and the removal surgery was performed for cautionary measures., the company will evaluate the type of wear particles present and ask the surgeon if swab or tissue samples were procured at the site of the discoloration.Upon completion of the investigation, the present complaint will be updated accordingly.The risk of inflammation has been assessed and found to be acceptable ((b)(4)) this complaint does not raise the probability rate.At the time of this report ( (b)(6) 2021), the company's incident rate of noise is (b)(4) the company continues to monitor this type of event routinely.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

On (b)(6) 2021, the distributor updated the company that patient no 181 has removal surgery of apifix system.The patient complained about a clicking noise 30-50 times a day associated with a pain impulse.Removal surgery did not result in any indication of a possible cause.No infection.

• Brand Name: MID-C 105L
• 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: 12602568
• MDR Text Key: 275891988
• Report Number: 3013461531-2021-00031
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2021

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: 06/01/2022
• Device Model Number: MID-C 105L
• Device Catalogue Number: AF105
• Device Lot Number: AF 06-01-17
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 10/09/2021
• Date Device Manufactured: 06/01/2017
• 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