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

Catalog Number A1059

Device Problems Decrease in Pressure (1490); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A1059 skull clamp lost torque pressure on the patient's head.Additional information has been requested.

Manufacturer Narrative

Medwatch (b)(4) received 22may2017 with the following information: incident date: (b)(6) 2017.Event description: upon removal of the surgical drape, a 3.5 cm laceration noted on right side of patient's head during pin/tong removal.Procedure: posterior cervical (c2-t2) fusion, decompressive laminectomy (c3-c7) integra has completed their internal investigation on may 16, 2017.Results: evaluation of returned device; complaint not confirmed - no issues observed.Unit cleaned per protocol 1907.The unit was setup per the ifu, then the part passed the 1101 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.Unit needs heli-coils added to large stardust threads.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 root cause for this failure was damaged internal threads near the starburst feature and the device being out of adjustment.

• Brand Name: MAYFIELD MODIFIED 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: 6515892
• MDR Text Key: 73818605
• Report Number: 3004608878-2017-00137
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• 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: 04/06/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• 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: 09/12/2011
• 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