DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 N/A 01.03956.040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-06 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 N/A 01.03956.040 manufactured by Zimmer Gmbh.

Event Text Entries

[99073134] The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. The manufacturer did not receive x-rays, or other source documents for review. As no lot number was provided, the device history records could not be reviewed. 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 cmp(b)(4).
Patient Sequence No: 1, Text Type: N, H10


[99073135] It was reported that the patient had a revision procedure two years and four months post-implantation due to overcompensation. Attempts to obtain additional information have been made; however, no more is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00229
MDR Report Key7243331
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-02-06
Date of Report2018-08-06
Date of Event2018-01-10
Date Mfgr Received2018-06-21
Device Manufacturer Date2016-01-05
Date Added to Maude2018-02-06
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 Report3

Device Details

Brand NameDYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40
Generic NameDYNESYS TOP-LOADING SPINAL SYSTEM
Product CodeNQP
Date Received2018-02-06
Returned To Mfg2018-05-02
Model NumberN/A
Catalog Number01.03956.040
Lot Number2842193
ID Number00889024481619
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2018-02-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.