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); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

Patient 3: laceration was reported.The facility is unable to identify which clamp(s) the laceration occurred with, therefore; only one skull clamp has been returned to date under mfg.Report number 3004608878-2017-00188.Additional information has been requested.Linked to mfg.Report number 3004608878-2017-00188 and 3004608878-2017-00189.

Manufacturer Narrative

Investigation completed 06/23/2017.Device history record reviewed for work order # (b)(4) lot/ 031 manufactured on 12/6/2002 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points except for rejected product labels which were replaced.No service history is on file for this device.No manufacturing or design related trend has 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.In summary, root cause for return was not confirmed.Device passed all required functional testing.General maintenance is required.No prior service history.Root cause cannot be determined; general maintenance and cleaning required.

• 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: 6635036
• MDR Text Key: 77393970
• Report Number: 3004608878-2017-00190
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2000
• 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: 07/12/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2002
• 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