FDA.reportPublic FDA data

MAUDE MDR 4234423

MDR report key
4234423
Report number
3003853072-2014-00036
Event key
0
Event type
3
Date received
2014-10-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SCOTT LAPOINTE
Address
7375 BUSH LAKE RD. MINNEAPOLIS MN 55439 US
Phone
952-952-9528
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNIVERSAL CLAMP GENERICUNIVERSAL CLAMP GENERICZIMMER SPINEOWISN2027 UNIVERSALSN2027 UNIVERSALR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-3101. R

Event Narratives#

D

Patient 1

SAME CASE AS: 3003853072-2014-00035. INFO RECEIVED FROM JOURNAL ARTICLE. PT UNDERWENT SURGERY THEN EXPERIENCED IMPLANT-RELATED COMPLICATIONS WITH DEVELOPMENT OF AN ASEPTIC SOFT TISSUE REACTION WITH GRANULOMAS ADJACENT TO THE SUBLAMINAR POLYETHYLENE TEREPHTHALATE STRAPSETITANIUM CLAMP MECHANISM OF THE DEVICE 8 MONTHS AFTER AIS CORRECTION SURGERY.