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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG&CO KG KERRISON BLK COATED 130 UP 180X1MM THIN; MICRO NEUROSURGICAL INSTR./BONE PUNC
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AESCULAP AG&CO KG KERRISON BLK COATED 130 UP 180X1MM THIN; MICRO NEUROSURGICAL INSTR./BONE PUNC Back to Search Results
Model Number FK906B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Other  
Event Description
Country of complaint: (b)(6).Complaint description: tip broke during surgery.
 
Manufacturer Narrative
Us reporting agent notified: (b)(6) 2014.Complaint description: tip broke during surgery.There are no hints for product or material deviations.Hardness and material correspond to the specification.There is no oem stock of this unit product code and lot number.No further patient information and/or delay information was provided at the time of this report.
 
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Brand Name
KERRISON BLK COATED 130 UP 180X1MM THIN
Type of Device
MICRO NEUROSURGICAL INSTR./BONE PUNC
Manufacturer (Section D)
AESCULAP AG&CO KG
po box 40
tuttlingen 7850 1
GM  78501
Manufacturer (Section G)
AESCULAP AG&CO KG
po box 40
tuttlingen 7850 1
GM   78501
Manufacturer Contact
michelle link
615 lambert pointe drive
hazelwood, MO 63042
3145515938
MDR Report Key4364605
MDR Text Key5292754
Report Number2916714-2014-00872
Device Sequence Number1
Product Code HTX
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFK906B
Device Catalogue NumberFK906B
Date Manufacturer Received06/20/2014
Was Device Evaluated by Manufacturer? Yes
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;
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