MAUDE Adverse Event Report: UNKNOWN MAYFIELD TRANSLUCENT C-CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Patient is placed in mayfield pins using translucent mayfield c clamp.C clamp would not release and was stuck on patient's head.Surgeon had to break radiolucent mayfield c clamp with pliers to get it off patient's head.C clamp that was broken sent out for repair and regular c clamp had to be used for case and patient had to be sent down to ir after case to have angiogram done because it could not be done intraoperative due to not having another working radiolucent c clamp available.Fda safety report id #: (b)(4).

• Brand Name: MAYFIELD TRANSLUCENT C-CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10245090
• MDR Text Key: 198192349
• Report Number: MW5095421
• 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: 07/02/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 110