MANDIBLE ANGLE - RIGHT - 47MM 7536

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-02 for MANDIBLE ANGLE - RIGHT - 47MM 7536 manufactured by Stryker Orthobiologics-malvern.

Event Text Entries

[81605726] Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Discarded at facility.
Patient Sequence No: 1, Text Type: N, H10


[81605727] It was reported that the patient had the device implanted in (b)(6) 2017 and then developed local inflammation and pain in the left side. The patient was also dissatisfied with the asymmetrical end result. Because of these reasons, the implant was removed in (b)(6) 2017. No dislocation of implants or loosening of screws were observed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2017-00192
MDR Report Key6760248
Report SourceHEALTH PROFESSIONAL
Date Received2017-08-02
Date of Report2017-08-02
Date of Event2017-07-04
Date Mfgr Received2017-07-05
Date Added to Maude2017-08-02
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 PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER ORTHOBIOLOGICS-MALVERN
Manufacturer Street45 GREAT VALLEY PARKWAY
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal Code19355
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMANDIBLE ANGLE - RIGHT - 47MM
Generic NameIMPLANT
Product CodeFWP
Date Received2017-08-02
Catalog Number7536
Lot NumberA1508063
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOBIOLOGICS-MALVERN
Manufacturer Address45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-08-02

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