FDA.reportPublic FDA data

MAUDE MDR 5458363

MDR report key
5458363
Report number
0008031020-2016-00081
Event key
0
Event type
3
Date of event
2016-01-27
Date received
2016-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1ANCHORAGE SCREWIMPLANTSTRYKER GMBHOATUNK_SELUNKNOWNN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-2401. O

Event Narratives#

N

Patient 1

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

D

Patient 1

IT WAS REPORTED BY THE DISTRIBUTION MANAGER THAT THE SCREW WENT THROUGH THE PLATE DURING SURGERY SO ANOTHER PLATE AND SCREW WAS USED TO COMPLETE THE SURGERY. NO COMPLICATIONS OR DELAY.

N

Patient 1

THE REPORTED INCIDENT THAT AN UNKNOWN ANCHORAGE SCREW WAS ALLEGED OF ISSUE S-41 (POOR FIXATION) COULD BE CONFIRMED SINCE THIS IS A KNOWN DESIGN ISSUE. THE ROOT CAUSE OF THIS POSITIONING ISSUE HAS BEEN IDENTIFIED AS A DESIGN ISSUE. THE NC 565281 HAS BEEN OPENED FOR RECURRING ISSUE. THE THRESHOLD DEFINED IN THE RISK MANAGEMENT FILE WAS NOT EXCEEDED. DESIGN IMPROVEMENT ACTIONS WERE IDENTIFIED IN CAPA (B)(4). DESIGN IMPROVEMENTS CONSIST IN CHANGING TOLERANCES OF THE SCREW HEAD IN ORDER TO STRENGTHEN THE CONNECTIVITY BETWEEN PLATE AND SCREWS. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. DEVICE WAS NOT RETURNED.

D

Patient 1

IT WAS REPORTED BY THE DISTRIBUTION MANAGER THAT THE SCREW WENT THROUGH THE PLATE DURING SURGERY SO ANOTHER PLATE AND SCREW WAS USED TO COMPLETE THE SURGERY. NO COMPLICATIONS OR DELAY.