• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5100060001
Device Problem Failure to Auto Stop (2938)
Patient Problem Abrasion (1689)
Event Date 08/31/2016
Event Type  Injury  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during a frontal craniotomy for excision of meningioma, the perforator did not stop.It was also reported that the dura was torn and the underlying brain was injured.It was further reported that the procedure was completed and meningioma was removed without any further complications.
 
Manufacturer Narrative
The quality investigation is complete.
 
Event Description
It was reported that during a frontal craniotomy for excision of meningioma, the perforator did not stop.It was also reported that the dura was torn and the underlying brain was injured.It was further reported that the procedure was completed and meningioma was removed without any further complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key5979729
MDR Text Key55704048
Report Number0001811755-2016-02395
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2017
Device Catalogue Number5100060001
Device Lot Number16130027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2016
Initial Date FDA Received09/27/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-