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

Catalog Number A1108

Device Problems Detachment Of Device Component (1104); Device Slipped (1584); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The pin from bottom of the skull clamp came out.It was unknown if there was any patient contact or not.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 07/28/2016.The device was not returned by the customer for evaluation.The lot number was also not provided.The most likely lot numbers could be 129 or 137.Lot# 129: this device was manufactured on december 31st, 2012 and a review of dhrs containing lot code 129 showed that the following lots passed the required inspection points without reworks, mrrs or variances: service history: date of service: 04/07/2014 lot# 137: this device was manufactured on 09/19/2013 and a review of work order (b)(4) ((b)(4)) containing lot 137 and serial number (b)(4) showed that this device passed the required inspection points without reworks, variances or mrrs.There is no service history for this device.No manufacturing or design related trend has been identified.In summary - the device was not released for evaluation therefore the root cause to the end user's experience could not be determined.

• Brand Name: MAYFIELD TRIAD 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: 5663864
• MDR Text Key: 46313847
• Report Number: 3004608878-2016-00122
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1108
• Device Lot Number: 129 OR 137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• 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