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

Catalog Number A2000

Device Problems Device Slipped (1584); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 05/21/2017

Event Type  Injury  

Event Description

Patient 1.Torque screw failed to engage; laceration occurred.Additional information has been requested.Linked to mfg.Report number 3004608878-2017-00190 and 3004608878-2017-00189.

Manufacturer Narrative

Investigation completed 06/29/2017.Device history reviewed.This is a device that has been in use since 2003 marked with lot number 031.There are no suspected manufacturing defects device was manufactured march 31, 2003 and has no previous service history.A review of complaint management system from 5/22/2015 to 5/22/2017 for this reported failure using key word "laceration" for product id a2000 shows that 7 complaints were received including this case.No new design or manufacturing trends have been identified.The returned unit has passed all specific functional testing requirements, except for the piston was started after starting line and could not achieve proper pressure from torque knob will bottom out before proper pressure could be reached, but root cause cannot be determined; the root cause cannot be determined; the failure was not confirmed; all items passed evaluation.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6635034
• MDR Text Key: 77397383
• Report Number: 3004608878-2017-00188
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

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: A2000
• Device Lot Number: 031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/12/2017
• 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
• Patient Outcome(s): Other; Required Intervention