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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS IMPLANT

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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS IMPLANT Back to Search Results
Model Number 60-000-23-09
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the implant did not fit as expected. Surgery was completed with alternate product.
 
Manufacturer Narrative
A stereo microscope investigation revealed that the returned device was cut in to pieces. Further observation determined there were no indications of material or manufacturing defects. The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm. During the investigation the product lot number identified was reviewed in the device history records. The dhr review showed no discrepancies or anomalies. Due to the device being cut in to pieces the root cause for the failure cannot be determined.
 
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Brand NameIPS
Type of DeviceIMPLANT
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM 78570
Manufacturer (Section G)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM 78570
Manufacturer Contact
jennifer damato
p.o. box 16369
jacksonville, FL 32245
9046417746
MDR Report Key8121218
MDR Text Key128936012
Report Number9610905-2018-00322
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00888118100139
UDI-Public(01)00888118100139
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-000-23-09
Device Lot Number8000001540
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/30/2019
Event Location Hospital
Date Report to Manufacturer11/05/2018
Date Manufacturer Received01/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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