FDA.reportPublic FDA data

MAUDE MDR 9709333

MDR report key
9709333
Report number
0001032347-2020-00107
Event key
0
Event type
3
Date received
2020-02-13
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. JENNIFER DELANEY
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
1HTR-PMI A.B. 1953-20190619 RIGHT TOP PARIETAL IMPLANTCUSTOM MADE DEVICEBIOMET MICROFIXATIONKKYN/APM622209917120R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1301. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, BUT A REVISION IS PLANNED FOR A LATER UNSPECIFIED DATE AT WHICH TIME THE DEVICE MAY BE RETURNED FOR TESTING. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00108, 0001032347-2020-00109. CONCOMITANT MEDICAL PRODUCTS: HTR-PMI A.B. 1953-20190619 RIGHT TOP PARIETAL IMPLANT, PART# PM622209, LOT# 917120; 1.5MM SYSTEM 4 HOLE EXTRA LONG STRAIGHT PLATE, PART# 01-7048, LOT# UNKNOWN; 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 91-6104, LOT# UNKNOWN; UNKNOWN SCREWS, PART# UNKNOWN, LOT# UNKNOWN. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ? (B)(6).

D

Patient 1

IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION OF A CUSTOM CRANIAL PLATE DUE TO UNSPECIFIED MEDICAL ISSUES. THE CUSTOM CRANIAL IMPLANT WILL BE REMOVED AND WILL BE REPLACED WITH A NEW CUSTOM CRANIAL IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.