TI MATRIXNEURO SCREW SELF-DRILLING 5MM 04.503.105.01S

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 2018-05-15 for TI MATRIXNEURO SCREW SELF-DRILLING 5MM 04.503.105.01S manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[108274236] Additional narrative: patient information is unknown. Additional procode: gxr. Device has not been 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


[108274237] Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the surgeon requested for the matrix system to reinsert the bone back to head. While the surgeon was screwing the bone and the plate the head of the screw come off from the tail. The surgeon tried another 4 screws and all the heads came off from the tails. They removed the system from the sterile field and used a different kit to continue the operation. The surgeon did try to remove the broken screws but he abandoned the attempt as he would have damaged the bone flap. There was no harm to the patient as the screws were being screwed into the hole on the plate on the scrub nurses trolley not in the patient? S head. Patient status is unknown. Concomitant devices: unknown matrixneuro plate (part/lot number: unknown, quantity 1). This report is for a ti matrixneuro screw self-drilling 5mm. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2018-53766
MDR Report Key7514677
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-05-15
Date of Report2018-04-25
Date of Event2018-04-20
Date Mfgr Received2018-07-23
Device Manufacturer Date2018-02-27
Date Added to Maude2018-05-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL COTE
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1WERK BETTLACH (CH)
Manufacturer StreetMURACHERSTRASSE 3
Manufacturer CityBETTLACH CO 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 Received2018-05-15
Returned To Mfg2018-06-11
Catalog Number04.503.105.01S
Lot NumberL789487
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-15

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