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

Catalog Number A1059

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); No Information (3190)

Event Type  Injury  

Event Description

It was reported that the mayfield modified skull clamp was involved in a patient incident with a possible laceration.Additional request for information has been sent.

Manufacturer Narrative

Investigation completed 9/18/2017.Device history record reviewed for sn (b)(4) work order /(b)(4) lot/ 139 a total of (b)(4) were manufactured on 11/25/2010 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points except for rejected product labels which were replaced.No service history is on file for this device.No manufacturing or design related trend has been identified.Root cause analysis -is undetermined at this time.The customer complaint was not confirmed -.With respect to the returned unit it has passed all specific functional testing requirements.It was noted that the lock had rotational movement when unit is not under pressure, but his is not a rejectable characteristic and this would not have caused a slippage.When unit is properly positioned and put under pressure, the unit did not slip.General maintenance and cleaning required.

• 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 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6867976
• MDR Text Key: 86259661
• Report Number: 3004608878-2017-00269
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2010
• 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 Outcome(s): Other