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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 6.5 X 45MM MULTIAXIAL REDUCTION SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

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ZIMMER BIOMET SPINE INC. 6.5 X 45MM MULTIAXIAL REDUCTION SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Back to Search Results
Catalog Number 2000-7435
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
Udi number: (b)(4).Without 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.
 
Event Description
It was reported that during surgery, the head of the screw was unable to rotate.The screw was removed and replaced with a new one.There were no reported patient impacts.
 
Manufacturer Narrative
Additional information in d10, h3, and h6: method, results, and conclusions codes.The returned screw was examined.The tulip head was found to bind up when attempting to rotate it.It is possible that damage to the screw head during insertion led to this binding seen.A review of the dhr did not find any issues which would have contributed to this event.
 
Event Description
It was reported that during surgery, the head of the screw was unable to rotate.The screw was removed and replaced with a new one.There were no reported patient impacts.
 
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Brand Name
6.5 X 45MM MULTIAXIAL REDUCTION SCREW
Type of Device
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key8876847
MDR Text Key153868645
Report Number3012447612-2019-00329
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
PMA/PMN Number
K061441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2000-7435
Device Lot NumberJ3592388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received08/08/2019
Supplement Dates Manufacturer Received01/14/2020
Supplement Dates FDA Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age49 YR
Patient Weight105
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