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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR CUSTOMIZED CRANIAL-S; IMPLANT
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STRYKER LEIBINGER FREIBURG MEDPOR CUSTOMIZED CRANIAL-S; IMPLANT Back to Search Results
Model Number 5444-0-110
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2022
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
 
Event Description
It was reported that during the procedure to remove and replace the implant, it was discovered the new implant did not fit as expected and could not be used.A revision surgery will need to be performed.
 
Event Description
It was reported that during the procedure to remove and replace the implant, it was discovered the new implant did not fit as expected and could not be used.A revision surgery will need to be performed.
 
Manufacturer Narrative
It was confirmed that the defect site was not cranialized or obliterated according to the warning ¿sinus reconstruction¿ in the design proposal.The sales rep agreed that not removing the bone was the main contributing factor resulting the implant not to fit into the defect site summarizing all obtained information, the complaint root cause of the complaint could be determined.Without the surgeon removing the bone fragments the implant did not fit as expected.
 
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Brand Name
MEDPOR CUSTOMIZED CRANIAL-S
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM  D-79111
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM   D-79111
Manufacturer Contact
rylee koole
boetzingerstr. 41
freiburg D-791-11
GM   D-79111
76145120
MDR Report Key14917627
MDR Text Key295311588
Report Number0008010177-2022-00020
Device Sequence Number1
Product Code FWP
UDI-Device Identifier07613252457626
UDI-Public07613252457626
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5444-0-110
Device Catalogue Number54440110
Device Lot Number2205191047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/08/2022
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) Required Intervention;
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