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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE C-SHAPE SLEEVE LOCKER SHORT

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ZIMMER SPINE C-SHAPE SLEEVE LOCKER SHORT Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 07/08/2016
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Report four of four for the same event; see also 0002184052-2016-00150, 00151 and 00152.
 
Event Description
The sales associate reported non-functional instruments.During a case the sleeves were unable to be used during the nxt case.It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly, therefore not letting the screwdrivers to be seated in the screw head.The surgery was completed using the short sleeves and pins.The doctor had to change technique from true percutaneous, because the short sleeves were not long enough for the obese patient, to a mini open type approach.
 
Manufacturer Narrative
The returned device was evaluated.There were no discrepancies found and the device performed as expected during a functional evaluation.The complaint cannot be confirmed.A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
Manufacturer Narrative
Corrections to all fields.Further review of this report found that the event was incorrectly characterized.This event did not cause or contribute to any patient injury, and would not likely lead to a death or serious injury if this event type were to recur.
 
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Brand Name
C-SHAPE SLEEVE LOCKER SHORT
Type of Device
SLEEVE
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer (Section G)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer Contact
michelle cole
7375 bush lake road
minneapolis, MN 55439
9528325600
MDR Report Key5853973
MDR Text Key51387923
Report Number0002184052-2016-00153
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number3557-1001
Device Lot Number85XY
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2016
Initial Date FDA Received08/08/2016
Supplement Dates Manufacturer ReceivedNot provided
05/24/2018
Supplement Dates FDA Received03/25/2017
06/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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