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

Catalog Number A1114

Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 01/26/2017

Event Type  Injury  

Event Description

While prepping for a cervical case, the lock opened and patient slipped three times.Patient incurred a laceration in the scalp.Revision/medical intervention was required.Surgery delay was reported to be 1 hour.Additional information has been requested.

Manufacturer Narrative

Correction: initial mdr was submitted with awareness date of 04/06/2016.The correct awareness date should be 04/06/2017.Integra has completed their internal investigation on may 16, 2017.Results: evaluation of returned device; no issues observed.Unit cleaned per protocol 1107.The unit was setup per the ifu, then the part passed the1101 testing.With respect to the returned unit it has passed all specific functional testing requirements with the following exception: the lock had rotational movement when the unit was not under pressure.Dhr review; no abnormalities related to the reported failure.Complaints history; no manufacturing or design related trend has been identified.Post market information will continue to be monitored.Conclusion: the reported complaint was not confirmed.The unit was setup per the instructions for use and the part passed the1101 inspection testing.With respect to the returned unit it has passed all specific functional testing requirements with the following exception: the lock had rotational movement when the unit was not under pressure.The rotational movement would not have caused/contributed to the reported harm of slippage.When the unit is properly positioned and put under pressure, the unit will not slip.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6515896
• MDR Text Key: 73495242
• Report Number: 3004608878-2017-00136
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

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: A1114
• Device Lot Number: 159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2015
• 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