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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG UCENTUM; ROD, DIA 6.0MM, STRAIGHT, LENGTH 45MM

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ULRICH GMBH AND CO. KG UCENTUM; ROD, DIA 6.0MM, STRAIGHT, LENGTH 45MM Back to Search Results
Model Number CS 3807-045
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 02/07/2024
Event Type  Injury  
Event Description
A few weeks following the surgical procedure, it discovered that a rod was fractured.A revision surgery was required to replace it.Cause of the fracture is unknown.
 
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Brand Name
UCENTUM
Type of Device
ROD, DIA 6.0MM, STRAIGHT, LENGTH 45MM
Manufacturer (Section D)
ULRICH GMBH AND CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM  89081
Manufacturer (Section G)
ULRICH GMBH AND CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM   89081
Manufacturer Contact
andreas hilzenbecher
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM   89081
MDR Report Key18822296
MDR Text Key336740846
Report Number9612420-2024-00001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K123717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/01/2024
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 NumberCS 3807-045
Device Catalogue NumberCS 3807-045
Device Lot NumberU038012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2024
Initial Date FDA Received03/01/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/21/2022
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) Hospitalization; Required Intervention;
Patient Age83 YR
Patient SexMale
Patient Weight120 KG
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