MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD 2 SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

While on stretcher, patients head was pinned by the mayfield device by the provider.Patient was being positioned from supine to prone.Once prone on operating table, patient's head was being supported by provider and mayfield device.The three pins slipped from the patient's head and caused a 3-4inch laceration on the left side of patient's head.Patient then needed to be placed supine on stretcher to staple his/her laceration closed.Unsure what caused the headpiece to become loose and cause the patient's head to slip.From op report: please note that i cut patients scalp in the preoperative planning with the mayfield pins, which was repaired primarily with staples.Please note that clinical engineering has completed the functionality testing of the 4 mayfield headrest units used by the operating room, since the one used in the event was not sequestered or identified by its centrac number.See the devices listed below that were tested.Nosn535 1 in service 03/31/2020.Nosn535 2 in service 11/18/2019.Nosn535 3 in service 1/02/2020.Nosn535 4 in service 12/11/2019.

• Brand Name: MAYFIELD 2 SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 10860020
• MDR Text Key: 216877480
• Report Number: 10860020
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Weight: 80