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U.S. Department of Health and Human Services

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

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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS PLATE Back to Search Results
Model Number 60-000-23-09
Device Problems Device Issue (2379); Insufficient Information (3190)
Patient Problem Impaired Healing (2378)
Event Date 03/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00053, mdr 9610905-2018-00054.
 
Event Description
It was reported that after the patient received radiation the implant needs to be removed and replaced. Expected removal date (b)(6) 2018.
 
Manufacturer Narrative
An investigation was performed using a stereo microscope which revealed tensile cracks. 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. A review of the device history records was not possible due to no lot number identified. The investigation results conclude that the root cause cannot be determined since there was no failure found. If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
 
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Brand NameIPS
Type of DevicePLATE
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strabe 10
muhlheim/donau, 78570
GM 78570
Manufacturer (Section G)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strabe 10
muhlheim/donau, 78570
GM 78570
Manufacturer Contact
jennifer damato
p.o. box 16369
jacksonville, FL 32245
9046417746
MDR Report Key7506052
MDR Text Key107962746
Report Number9610905-2018-00052
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,Followup
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number60-000-23-09
Device Lot Number17007377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/16/2018
Event Location Hospital
Date Report to Manufacturer04/16/2018
Date Manufacturer Received08/24/2018
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 Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
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