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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 60-000-78-09
Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Patient Problems Impaired Healing (2378); Patient Problem/Medical Problem (2688)
Event Date 02/28/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's bone fractured during implantation due to poor bone quality and the plate had to be removed the following day. Ifu (b)(4) contraindications list "insufficient or inadequate bone tissue".
 
Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation. The complaint percentage was calculated and it is determined that the complaint percentage falls within the design risk limits adhered to at klm. The product device history records were also reviewed based on the lot number provided, no anomalies were found. Due to no device being returned the root case for the failure cannot be determined. 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 Key7330125
MDR Text Key102072790
Report Number9610905-2018-00034
Device Sequence Number1
Product Code GXN
UDI-Device Identifier0088811810080
UDI-Public(01)0088811810080
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062570
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 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number60-000-78-09
Device Lot NumberC9622286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer03/01/2018
Date Manufacturer Received04/06/2018
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: 03/12/2018 Patient Sequence Number: 1
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