MAUDE Adverse Event Report: PRO-MED INSTRUMENTS GMBH DORO MOUNT; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problem Device Slipped (1584)

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

Event Date 05/30/2012

Event Type  Injury  

Event Description

A medtronic representative reported that the arm holding the frame broke.They aborted navigation but continued the case.They were removing the bone flap after registering when the issue occurred.This was during an awake crani/biopsy.There was no impact to patient outcome.After the case, it was found that the imri arm slipped off the doro attachment because the doro attachment slid down the doro mount.There is no indication of a malfunction with any medtronic product.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DORO MOUNT
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): PRO-MED INSTRUMENTS GMBH
• MDR Report Key: 17532577
• MDR Text Key: 321141527
• Report Number: MW5139485
• Device Sequence Number: 1
• Product Code: HBL
• 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: 06/29/2012

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 27 YR