MAUDE Adverse Event Report: KOHLER NEEDLE HOLDER; HOLDER, NEEDLE; ORTHOPEDIC

Model Number 4068 NEEDLE HOLDER

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

When the doctor used the needle holder produced by kohler for oral implant surgery, the front end was broken, which did no harm to the patient, and the needle holder was replaced with a new one.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEEDLE HOLDER
• Type of Device: HOLDER, NEEDLE; ORTHOPEDIC
• Manufacturer (Section D): KOHLER
• MDR Report Key: 17488888
• MDR Text Key: 320687437
• Report Number: MW5121587
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4068 NEEDLE HOLDER
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1