MAUDE Adverse Event Report: PRO MED INSTRUMENTS INC. DORO 3 POINT HEAD HOLDER; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number 1001-001

Device Problems Mechanical Problem (1384); Activation Failure (3270)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Doro 3 point head holder - complete failure on the locking mechanism.See scanned pages.

• Brand Name: DORO 3 POINT HEAD HOLDER
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): PRO MED INSTRUMENTS INC.
• MDR Report Key: 16337786
• MDR Text Key: 309306615
• Report Number: MW5114816
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1001-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male