DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-04 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035 manufactured by Zimmer Gmbh.

Event Text Entries

[113160027] Additional concomitant medical products: dynesys lis, stabilizing cord, 200, catalog no. : 0103711200 ; lot no# unknown; dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, catalog no. : 0103956035 ; lot no# unknown; dynesys set screw spine impl win gen, catalog no. : unknown, lot no. : unknown; dynesys set screw spine impl win gen, catalog no: unknown, lot no. : unknown; dynesys staples spine impl win gen, catalog no. : 187701010, lot no. : unknown. Therapy date: (b)(6) 2014. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[113160028] Patient was implanted and underwent revision surgery due to overcorrection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00678
MDR Report Key7662107
Date Received2018-07-04
Date of Report2018-11-22
Date of Event2014-08-27
Date Mfgr Received2018-11-20
Date Added to Maude2018-07-04
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER GMBH
Manufacturer StreetSULZER ALLEE 8 SULZER INDUSTRIE PARK
Manufacturer CityWINTERTHUR 8404
Manufacturer CountrySZ
Manufacturer Postal Code8404
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameDYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35
Generic NameDYNESYS TOP-LOADING SPINAL SYSTEM
Product CodeNQP
Date Received2018-07-04
Model NumberN/A
Catalog Number01.03956.035
Lot NumberUNKNOWN
ID NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER GMBH
Manufacturer AddressSULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-07-04

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