DYNESYSTL, 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 from a health professional report with the FDA on 2018-07-03 for DYNESYSTL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35 N/A 01.03956.035 manufactured by Zimmer Gmbh.

Event Text Entries

[112994745] Concomitant medical products: item: dynesys tl, set screw catalog #: 01. 03810. 006 lot #: 2699345; item: dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35 catalog #: 01. 03956. 035 lot #: unkn; item: dynesys lis, stabilizing cord, 200 catalog #: 01. 03711. 200 lot #: 2751522; item: dynesys tl, ha pedicle screw, cannulated + set screw, 7. 2x50 catalog #: 01. 03957. 250 lot #: 2701342. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The manufacturer did not receive x-rays, or other source documents for review. The dhr check could not be performed for all parts as not all lot numbers are available. For the parts reported with lot number the device manufacturing quality records indicate that the released components met all requirements to perform as intended. An e-mail requesting additional information was sent on (b)(6) 2018 to the appropriate representatives. 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). Note: the same patient underwent a previous surgery reported in (b)(4). The following reports are associated with this event: 0009613350 - 2018 - 00668; 0009613350 - 2018 - 00669; 0009613350 - 2018 - 00670; 0009613350 - 2018 - 00672.
Patient Sequence No: 1, Text Type: N, H10


[112994746] It was reported that a patient was initially implanted with dynesys implants and underwent second revision due to over correction approximately five years post implantation. The surgeon confirms, that no hardware was removed during second revision, but additional screws were placed. Note: the dynesys products remain implanted. Hence, no explantation date is captured.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0009613350-2018-00671
MDR Report Key7657688
Report SourceHEALTH PROFESSIONAL
Date Received2018-07-03
Date of Report2018-11-22
Date of Event2018-06-01
Date Mfgr Received2018-11-19
Date Added to Maude2018-07-03
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 NameDYNESYSTL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X35
Generic NameDYNESYS TOP-LOADING SPINAL SYSTEM
Product CodeNQP
Date Received2018-07-03
Model NumberN/A
Catalog Number01.03956.035
Lot NumberUNK
ID NumberUNKNOWN
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 2018-07-03

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