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

Catalog Number A1059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/26/2021

Event Type  Injury  

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 mayfield modified skull clamp (a1059) caused less than 1cm long laceration to the patient at the right parietal area during a posterior cervical fusion case.The lacerated wound was stapled to close and the patient woke from anesthesia with no apparent other issues.The skull clamp was sequestered.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.Mayfield modified skull clamp (a1059) was returned for evaluation.The evaluation of the device could not duplicate the reported complaint.With respect to the returned unit it has passed all specific functional testing requirements.When unit is properly positioned and put under pressure unit would not have slipped.Unit needs to be machined to have heli-coils added to large starburst threads.General maintenance and cleaning required at this time.

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: 11872584
• MDR Text Key: 252389542
• Report Number: 3004608878-2021-00374
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1