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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW

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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW Back to Search Results
Model Number 25-092-08-91
Device Problems Break (1069); Component Falling (1105)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/29/2017
Event Type  Injury  
Event Description
As they were removing the screws the tip of the screw broke off in the patient.The broken piece of screw was left in the patient's maxilla.It was discovered in the post op x-ray after the case was completed.
 
Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.The review of the product device history records was performed on the lot number provided.In this investigation no anomalies were discovered.The root cause for the failure cannot be determined due to no device being returned.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 Name
LEVEL ONE CMF
Type of Device
SCREW
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 Key6527507
MDR Text Key73892461
Report Number9610905-2017-00039
Device Sequence Number1
Product Code DZL
UDI-Device Identifier00888118037206
UDI-Public(01)00888118037206
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2017
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
Device Operator Physician
Device Model Number25-092-08-91
Device Lot Number33180604
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/29/2017
Initial Date FDA Received04/27/2017
Supplement Dates Manufacturer Received03/29/2017
Supplement Dates FDA Received09/13/2017
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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