UNKNOWN_FRO_PRODUCT UNK_FRO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-26 for UNKNOWN_FRO_PRODUCT UNK_FRO manufactured by Stryker Leibinger Freiburg.

Event Text Entries

[184441247] Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device unable to be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[184441248] It was reported by the company representative that during the first pmd2 case, the left distractor locking mechanism got stuck halfway between lock and unlocked. When the surgeon went to distract the mandible on post-operation, the left distractor was stuck. During the second planned procedure, the surgeon found that the distractor was again stuck between lock and unlocked. He clicked the distractor into the unlock position and then back into the locked position. The distractor then operated normally.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2020-00010
MDR Report Key9758336
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2020-01-29
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KELLI DYKSTRA
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer CountryDE
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER LEIBINGER FREIBURG
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer CountryDE
Manufacturer Postal CodeD-79111
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN_FRO_PRODUCT
Generic NameDISTRACTOR
Product CodeMQN
Date Received2020-02-26
Catalog NumberUNK_FRO
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER LEIBINGER FREIBURG
Manufacturer AddressBOETZINGERSTR. 41 FREIBURG D-79111 DE D-79111


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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