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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE POWER KNOB ROD REDUCER SHORT

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ZIMMER SPINE POWER KNOB ROD REDUCER SHORT Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2016
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Report two of three for the same event; see also 0002184052-2016-00156 and 00158.
 
Event Description
It was reported that during surgery, while inserting the 5. 5 screw, the screw head got dis-mantled from the body. The screw broke while loading it on the driver. Therefore, another screw was used. In addition, the power knob reducer got stuck during the surgery and was not usable. And, the rod bender was not in the part of the set and should have been. It was confirmed there was a surgical delay longer than 30 minutes.
 
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Brand NamePOWER KNOB ROD REDUCER SHORT
Type of DeviceROD REDUCER
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 Key5857508
MDR Text Key51502648
Report Number0002184052-2016-00157
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number3567-10
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/09/2016 Patient Sequence Number: 1
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