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

Catalog Number A1114

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Head Injury (1879); Laceration(s) (1946); Injury (2348)

Event Date 10/19/2017

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2017, the mayfield infinity skull clamp cut the patient¿s head during surgery while trying to adjust it.No revision/medical intervention was required.It was unknown if there was a delay in surgery.Request for additional information was sent and on (b)(6) 2017, the customer reported that this is ¿all the information i am aware of¿.

Manufacturer Narrative

Integra has completed their internal investigation on november 15, 2017.Device history record reviewed for sn (b)(4) work order /(b)(4) lot/ 139 a total of (b)(4) were manufactured on 12/26/2013 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points.No manufacturing or design related trend has been identified.Post market information will continue to be monitored.Complaint confirmed.The returned unit did not meet all specific functional test.Unit received with the lock sticking when unit is unlocked and rotated.The lock will need new components added to replace worn internal parts; unit requires pm maintenance at this time.

• Brand Name: MAYFIELD INFINITY 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6978926
• MDR Text Key: 90284893
• Report Number: 3004608878-2017-00301
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2013
• 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