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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE SCREW TI 6.5X40MM SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. PEDICLE SCREW TI 6.5X40MM SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 7715-6540
Device Problem Biocompatibility (2886)
Patient Problem Reaction (2414)
Event Date 10/26/2018
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. 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. Reference reports 3012447612-2018-00942 thru 3012447612-2018-00952.
 
Event Description
It was reported that a patient developed an allergic reaction about 6-8 months post-operatively. The surgeon believes it may possibly be related to the implants. A course of action for treatment has not yet been decided upon. This is report nine of eleven for this event.
 
Manufacturer Narrative
Additional information: results and conclusions - the device was not returned for evaluation so no results are available and no conclusions can be drawn. The manufacturing records were unable to be reviewed since the lot number is unknown. Allergic reaction to the implant material is a known possible complication associated with the device per its labeling.
 
Event Description
It was reported that a patient developed an allergic reaction about 6-8 months post-operatively. The surgeon believes it may possibly be related to the implants. A course of action for treatment has not yet been decided upon. This is report nine of eleven for this event.
 
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Brand NamePEDICLE SCREW TI 6.5X40MM
Type of DeviceSPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8108297
MDR Text Key128487417
Report Number3012447612-2018-00950
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number7715-6540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2018 Patient Sequence Number: 1
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