FDA Adverse Event Other Summary report: N

MAYFIELD SKULL CLAMP

MDR report key: 900714 · Received October 29, 2004

Report

Report Number: 1525725-2004-00018
Event Type: Other
Date Received: October 29, 2004
Report Date: September 24, 2004
Manufacturer: SCHAERER MAYFIELD USA, INC.
Product Code: HBL
Removal / Correction Number: UNK
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SUSPECT DEVICE WAS RETURNED TO INTEGRA LIFESCIENCES CORP ON SEPTEMBER 29, 2004 FOR EVAL AND REPAIR. THE FOLLOWING IS A SUMMARY OF THE EVAL AND CONCLUSION RESULTS. EVAL: THE 80 POUND TORQUE KNOB TESTED GOOD ON PRESSURES OF 20, 40, 60 & 80 POUNDS. THE SWIVEL BASE HAD A LITTLE ROTATIONAL MOVEMENT IN THE LOCKED POSITION, BUT HAD A GOOD POSITIVE LOCK. THE ANODIZED FINISH WAS IN POOR CONDITION DUE TO IMPROPER CLEANINGS, BUT HAD NO EFFECT ON THE FUNCTION OF THIS UNIT. THE DEVICE WAS TESTED UNDER PRESSURE AND WHEN PROPERLY POSITIONED, ADJUSTED AND LOCKED, INTEGRA LIFESCIENCES WAS NOT ABLE TO DUPLICATE A CONDITION THAT WOULD RESULT IN A SLIPPAGE. THE DEVICE PERFORMED PROPERLY. CONCLUSION: BASED ON THE NATURE OF THE INQUIRY, INTEGRA LIFESCIENCES EVAL RESULTS, AND REPORTED INFO, NO DEFINITE CONCLUSION COULD BE DETERMINED AS TO HOW OR WHY THE DEVICE REPORTEDLY SLIPPED RESULTING IN A SCALP LACERATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. HOWEVER, AS AN AID TO THE NEURO STAFF AT THE HOSP, INTEGRA LIFESCIENCES SENT A COPY OF THE CD "MAYFIELD PROPER SKULL CLAMP POSITIONING." THE NEURO STAFF SHOULD FIND THIS INFO HELPFUL.

Description of Event or Problem · 1

PT LACERATION CAUSED WHEN HEAD SLIPPED. PT IN PRONE POSITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAYFIELD SKULL CLAMP	SKULL CLAMP	HBL	SCHAERER MAYFIELD USA, INC.	4-0-A-1059	037

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Other