FDA.reportPublic FDA data

MAUDE MDR 7122517

MDR report key
7122517
Report number
2210968-2017-71828
Event key
0
Event type
3
Date received
2017-12-15
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
DARLENE KYLE
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PDS PLATE UNKNOWN PRODUCTPOLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLEETHICON INC.NHBUNK* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-1501. R

Event Narratives#

N

Patient 1

PRODUCT COMPLAINT # (B)(4). (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: BRITISH JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY 51 (2013) E224?E229. HTTP://DX.DOI.ORG/10.1016/J.BJOMS.2013.01.016.

D

Patient 1

IT WAS REPORTED IN JOURNAL ARTICLE ?SECONDARY CORRECTION OF POSTTRAUMATIC ORBITAL WALL ADHESIONS BY MEMBRANES LAMINATED WITH AMNIOTIC MEMBRANE? THAT THE OBJECTIVE OF THIS STUDY WAS TO FIND OUT IF HUMAN AMNIOTIC MEMBRANE COULD BE USED FOR CORRECTIVE SURGERY AFTER TRAUMA TO THE ORBIT WALL. THE PATIENT WITH DEFECTIVE MOTILITY OF THE BULB AFTER FRACTURES OF THE ORBITAL FLOOR WAS TREATED AND HAD THE ORBITAL WALL REPAIRED AND POLYDIOXANONE FOIL WAS USED. TREATMENT OF LARGE BLOW-OUT FRACTURES WITH FOIL CAN LEAD TO ADHESIONS AND SCARS, RESULTING IN REDUCED MOTILITY OF THE BULB AND DIPLOPIA. THE PATIENT INSERTED WITH POLYDIOXANONE FOIL EXPERIENCED MODERATE RESTRICTION OF UP GAZE, MINOR RESTRICTION OF DOWN AND LATERAL GAZE, AND DIPLOPIA ON LATERAL AND DOWN GAZE. SECONDARY CORRECTION INVOLVED DETACHMENT OF ADHESIONS AND SCARS, REMOVAL OF POLYDIOXANONE FOIL, AND INSERTION OF AMNIOTIC MEMBRANE LAMINATED POLYGLACTIN910/POLYDIOXANONE PATCH. THE OUTCOME AFTER 3 MONTHS WAS FULL RANGE OF MOTILITY OF BULB AND NO DIPLOPIA. ADDITIONAL INFORMATION WILL BE REQUESTED.

N

Patient 1

PC(B)(4) DATE SENT TO THE FDA: (B)(6)/2018. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED? WHY DOES THE AUTHOR BELIEVE THAT THE SUTURE CONTRIBUTED TO THE EVENT AND NOT THE TITANIUM MESH?