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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 25-872-07-91
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Patient Problem Impaired Healing (2378)
Event Date 07/22/2021
Event Type  Injury  
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.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.The failure root cause cannot be determined due to the device not 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.
 
Event Description
It was reported a screw became loose likely due to poor bone quality; it was removed.
 
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Brand Name
LEVEL ONE CMF
Type of Device
SCREW
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM  78570
Manufacturer (Section G)
KLS MARTIN L.P.
p.o. box 16369
jacksonville FL 32245
Manufacturer Contact
jennifer damato
p.o. box 16369
jacksonville, FL 32245
9046417746
MDR Report Key12348170
MDR Text Key267462440
Report Number9610905-2021-00074
Device Sequence Number1
Product Code JEY
UDI-Device Identifier00888118046734
UDI-Public(01)00888118046734
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943347
Exemption Number2017029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/22/2021
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 Health Professional
Device Model Number25-872-07-91
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/22/2021
Initial Date FDA Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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