MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the head pin of the mayfield modified skull clamp (a1059) was released from the patient's head during transportation of the patient from the operating room (or).There was no patient harm or surgical delay.

Manufacturer Narrative

The mayfield skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.The evaluation of the device could not duplicate the reported complaint.The skull clamp has been tested with test pins and the complaint could not be confirmed.Further investigation showed that the skull clamp is obsolete and needs to be updated.This device exceeds its expected life of 7 years and it is highly recommended that the device be replaced (manufactured in 2007 ).It also has damaged threads and a discolored surface.Therefore the base, the swivel adapter and some worn off small parts will need to be replaced; the base assembly of the skull clamp is very old and needs to be overhauled.The unit needs replacement of the swivel adapter, preventative maintenance and replacement of worn parts.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11900615
• MDR Text Key: 253138207
• Report Number: 3004608878-2021-00382
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1