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

Catalog Number A1059

Device Problems Break (1069); Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

It was reported that the mayfield modified skull clamp was broken.The pressure screw released from the skull clamp causing the pin to slip and lacerated the scalp on a (b)(6) year-old female.An unspecified revision /medical intervention was reported.There was no delay in surgery.Request for additional information has been sent.

Manufacturer Narrative

Integra has completed their internal investigation on december 21, 2017.Failure analysis - complaint not confirmed - no issues observed.With respect to the returned unit it has passed all specific functional testing requirements.When unit is properly positioned and put under pressure the unit did not slip.Unit needs heli-coils added to large starburst threads for pm maintenance.General maintenance and cleaning required.Unit has never been sent in for pm maintenance.Device history review cannot be performed, the sn (b)(4) was given by the service group for tracking.The lot# is109, this product was unsterilized at original manufacture date.Trend analysis: two-year lookback from 11/28/2015 to 11/28/2017 for reported failure using the key words "broken clamp" "fracture" for product id a1059, shows that no additional complaints were received.No new design or manufacturing trends have been identified.Root cause is undetermined at this time.

• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7113710
• MDR Text Key: 94791787
• Report Number: 3004608878-2017-00327
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• 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
• Patient Age: 79 YR