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

Catalog Number A2000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device identifier # (b)(4).The unit was received with the hex bushing worn and the lock still moving after unit was lock down, needing to be replaced.General maintenance and cleaning required.Please note that the unit was manufactured in 2010 ( lot code 107) and is beyond integra's 7 years recommended life cycle.The reported complaint was confirmed.The complaint is likely caused by wear and tear / improper handling.The definite root cause could not be reliably determined.

Event Description

The customer reported that the a2000 mayfield 2000 skull clamp was not holding under pressure.Additional information received on 14aug2019 and 16aug2019 indicated that the device was not in contact with the patient.During inspection by the sales representative on (b)(6) 2019, the head holder was not mobile while under pressure.It seemed as though every part of the mechanics with this piece was locked up.Tried clamping it to something and tried utilizing it when connected to the base, it was not performing as it should.

• Brand Name: MAYFIELD 2000 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 8943205
• MDR Text Key: 189918443
• Report Number: 3004608878-2019-00347
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2019

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: A2000
• Device Lot Number: 107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/28/2019
• 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