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

Catalog Number XXX-MAYFIELD SKULL CLAMP

Device Problem Mechanical Problem (1384)

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

Event Date 06/29/2021

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

We received medwatch u/f importer report #(b)(4) with the following nformation: "resident was placing the patient in the mayfield head holder, while attending was present.The head holder would not hold beyond 40 lbs.Of pressure.The head holder was removed.The pin site was inspected for fracture into the bone.Given the fact that the head holder could not hold pressure, patient taken for a ct scan while she was intubated.Patient then came back to or, extubated and went to the recovery room.Surgery was aborted.".

Manufacturer Narrative

The mayfield skull clamp was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNKNOWN MAYFIELD SKULL CLAMP
• Type of Device: SKULLCLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13508062
• MDR Text Key: 286580599
• Report Number: 3004608878-2022-00023
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-MAYFIELD SKULL CLAMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White