TI MATRIXNEURO SCREW SELF-DRILLING 5MM 04.503.105.04S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-08 for TI MATRIXNEURO SCREW SELF-DRILLING 5MM 04.503.105.04S manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[116395924] Additional procodes: gxr, jey. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history records review has been requested. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[116395925] Device report from synthes (b)(4) reports an event in (b)(6) as follows: the customer reports that during a cranial closure procedure on (b)(6) 2018, the screw thread blocked in the bone and the screw head broke. A second screw also broke in the same manner. All fragments were removed from the patient. The surgeon used other screws to complete the procedure. There was no surgical delay and no consequences for the patient. This report is for a titanium (ti) matrixneuro screw self-drilling 5mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2018-55544
MDR Report Key7761766
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-08-08
Date of Report2018-07-19
Date of Event2018-06-27
Date Mfgr Received2018-09-11
Device Manufacturer Date2015-04-10
Date Added to Maude2018-08-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL COTE
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1WERK BETTLACH (CH)
Manufacturer StreetMURACHERSTRASSE 3
Manufacturer CityBETTLACH 2544
Manufacturer CountrySZ
Manufacturer Postal Code2544
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTI MATRIXNEURO SCREW SELF-DRILLING 5MM
Generic NamePLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
Product CodeGWO
Date Received2018-08-08
Catalog Number04.503.105.04S
Lot Number9437898
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-08

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