FDA.reportPublic FDA data

MAUDE MDR 8349595

MDR report key
8349595
Report number
1818910-2019-84943
Event key
0
Event type
3
Date of event
2019-01-07
Date received
2019-02-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KARA DITTY-BOVARD
Address
1210 WARD AVENUE WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATTUNE PATELLA COMPRESSION RNGATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPSDEPUY IRELAND 9616671HWN254501042R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-190

Event Narratives#

N

Patient 1

PRODUCT COMPLAINT : (B)(4). DEVICE WILL NOT CLAMP TIGHTLY, WILL NOT HOLD. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

NURSES REPORTED ATTUNE PATELLA CLAMPS ARE NOT HOLDING TOGETHER WELL