FDA.reportPublic FDA data

MAUDE MDR 9832380

MDR report key
9832380
Report number
1818910-2020-07910
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KARA DITTY-BOVARD
Address
700 ORTHOPAEDIC DR. WARSAW IN 46581 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DXTEND SCREW LOCK D4.5X36MMDELTA XTEND IMPLANTS : SCREWSDEPUY FRANCE SAS - 3003895575HSD1307900361307900365354590N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-130

Event Narratives#

N

Patient 1

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

AFTER THE LOCKING SCREW HAD BEEN PLACED, THE SURGEON NOTICED THAT THE LOCKING BOLT WAS NO LONGER PLACED INSIDE THE SCREW. THE LOCKING BOLT FELL ON THE GROUND. THE TEAM TRIED TO USE THE LOCKING BOLT OF ANOTHER LOCKING SCREW, BUT IT DID NOT SOLVE THE PROBLEM. THE SIZE 36 HAD TO BE REMOVED AND A NEW ONE WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS A TEN-MINUTE SURGICAL DELAY.

N

Patient 1

PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE RETURNED PRODUCT WAS EXAMINED AND NO MANUFACTURING OR DESIGN DEFECT WAS FOUND. THE REASON FOR FAILURE WAS UNDETERMINED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.