Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS Back to Search Results
Model Number 60-000-23-09
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.Based on the information provided the most likely root cause is patient condition.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
 
Event or Problem Description
Peek implant was removed to address patient infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IPS
Common Device Name
IPS
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM  78570
MDR Report Key9498324
Report Number9610905-2019-00233
Device Sequence Number19578651
Product Code GXN
UDI-Device Identifier00888118100139
UDI-Public(01)00888118100139
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K072707
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/29/2019
Report Date (Section F) 11/29/2019
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? No
Operator of Device Health Professional
Device Model Number60-000-23-09
Device Lot Number8000005319
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/29/2019
Event Location Hospital
Date Report to Manufacturer11/29/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/29/2019
Initial Report FDA Received Date12/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-