MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 RADIOLUCENT SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A2002

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the lock screw broke.Additional information has been requested.Linked to mfg.Report number: 3004608878-2017-00249.

Manufacturer Narrative

Investigation completed 10/10/2017.A two year look back from 08/01/2015 to 08/01/2017 for this reported failure and or related to "break¿ or "broken" for product family (a2002) show no new design or manufacturing trends.Complaint was confirmed, the returned unit did not meet all specific functional tests, specifically the plunger cap is broken off of the plunger stud, but a root cause to how it broke off could not be determined.Unit has not been serviced since 2013.

• Brand Name: MAYFIELD 2000 RADIOLUCENT 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6810429
• MDR Text Key: 83693746
• Report Number: 3004608878-2017-00250
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K953124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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