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

Model Number A1059

Device Problem Device Slipped (1584)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

Adult female patient presented to or for chiari decompression/microdissection.Mayfield skull clamp/skull pins were placed with patient supine on stretcher.When patient was turned to the prone position bleeding was noted from the left side of the head.The patient was immediately returned to the supine position on the stretcher so that the surgeon could investigate the cause of the bleeding.The surgeon stated that the skull pins had slipped, resulting in a scalp laceration approximately 2.5 inches long on the left side of the patient's head.The mayfield skull clamp was immediately sequestered.The surgeon closed the laceration with staples, a replacement device was obtained, and the patient was repositioned without incident.Surgery then proceeded as planned.The mayfield skull clamp was shipped to the manufacturer for evaluation/repair.The repair report notes that the index knob was loose and easy to turn.The device passed all other functional tests.Manufacturer response for mayfield modified skull clamp, mayfield (per site reporter): repair report states that the complaint was confirmed via inspection of the unit.The index knob was loose and easy to turn.The clamp passed all other functional testing.

• Brand Name: MAYFIELD
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 11884845
• MDR Text Key: 252680694
• Report Number: 11884845
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2021
• 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: 13870 DA
• Patient Weight: 96