FDA.reportPublic FDA data

MAUDE MDR 8157434

MDR report key
8157434
Report number
0001032347-2018-00856
Event key
0
Event type
3
Date of event
2018-07-13
Date received
2018-12-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. MICHELLE COLE
Address
1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US
Phone
904-904-9047
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
11.5 MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5-PK, 1.5 X 5 MMFASTENER, SCREW, CRANIOPLASTYBIOMET MICROFIXATIONHBWN/A95-6105414550R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-1201. R

Event Narratives#

N

Patient 1

(B)(4). DEVICE PRODUCT CODE: HBW. (B)(4). REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THE SCREW FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW OF THE SAME SIZE. IT IS STATED THE SURGICAL TECHNIQUE WAS NOT FOLLOWED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.