FDA.reportPublic FDA data

MAUDE MDR 7966724

MDR report key
7966724
Report number
0008031020-2018-00790
Event key
0
Event type
3
Date of event
2018-09-14
Date received
2018-10-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ROSE HAAS
Address
325 CORPORATE DRIVE MAHWAH NJ 07430 US
Phone
201-201-2018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LOW-PROFILE TITANIUM MINI-PLATING SYSTEMIMPLANTSTRYKER GMBHGWOUNK_SELR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-1501. O

Event Narratives#

N

Patient 1

IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE DISPOSITION IS UNKNOWN.

D

Patient 1

THE MANUFACTURER BECAME AWARE OF A STUDY FROM ST JAMES?S UNIVERSITY HOSPITAL, LEEDS, UK. THE TITLE OF THIS STUDY IS ?THE ROLE OF LOW-PROFILE TITANIUM MINIPLATES IN EMERGENCY AND ELECTIVE HAND SURGERY?, WHICH WAS PUBLISHED IN JUNE 1999 AND IS ASSOCIATED WITH ?LEIBINGER LOW PROFILE TITANIUM MINI-PLATING SYSTEM?. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN FEBRUARY 1994 TO FEBRUARY 1997. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE; A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHORS OF THE PUBLICATION. THEREFORE, 25 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE STUDY. THIS PRODUCT INQUIRY ADDRESSES REDUCED RANGE OF MOVEMENT. 9 OUT OF 11 CASES.