COBB SPINAL ELEVATOR-HEAVY DUTY 1/2 INCH WIDTH N/A 00289400200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-21 for COBB SPINAL ELEVATOR-HEAVY DUTY 1/2 INCH WIDTH N/A 00289400200 manufactured by Zimmer, Inc..

Event Text Entries

[73670232] (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[73670233] It is reported that the device tip detached from the handle during surgery. The surgeon finished the surgery with an alternative device. No serious injury has been reported for this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2017-02700
MDR Report Key6513433
Date Received2017-04-21
Date of Report2017-07-08
Date of Event2017-03-10
Date Mfgr Received2017-07-06
Device Manufacturer Date2014-10-21
Date Added to Maude2017-04-21
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, INC.
Manufacturer Street1800 WEST CENTER STREET
Manufacturer CityWARSAW IN 46580
Manufacturer CountryUS
Manufacturer Postal Code46580
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report0

Device Details

Brand NameCOBB SPINAL ELEVATOR-HEAVY DUTY 1/2 INCH WIDTH
Generic NameELEVATOR, SURGICAL
Product CodeGEG
Date Received2017-04-21
Returned To Mfg2017-06-02
Model NumberN/A
Catalog Number00289400200
Lot Number62850826
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER, INC.
Manufacturer Address1800 WEST CENTER STREET WARSAW IN 46580 US 46580


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-21

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.