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

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Abrasion (1689); Injury (2348)

Event Type  Injury  

Event Description

A possible slip was reported.The patient had a "scratch" after the case.Date of the incident was unknown.Additional information was received from the customer on 11jun2015: the incident had happened long ago and the neuro coordinator only came to know about the incident weeks after.She stated the patient just had a scratch, not a serious injury.She mentioned that the physician was training his pa (physician assistant) when the incident occurred.She had no other information to provide.

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Integra has completed their internal investigation 07/10/2015.Results: a dhr review cannot be performed at this time as the lot number was not provided or was the product sent in for inspection for the device involved could not be located by the end user.No manufacturing or design related trend has been identified.Conclusion: in summary - the device was not released for evaluation therefore the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.

• Brand Name: MAYFIEL MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4864904
• MDR Text Key: 5864014
• Report Number: 3004608878-2015-00177
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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