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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE SCREW, UNKNOWN TYPE OR SIZE; VITALITY SPINAL FIXATION SYSTEM

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ZIMMER BIOMET SPINE INC. PEDICLE SCREW, UNKNOWN TYPE OR SIZE; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Phone number: (b)(6); the software would not allow the phone number to be entered.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.
 
Event Description
It was reported a closure top back backed out of a pedicle screw post-operatively.No further information has been provided.This is report two of two for this event.
 
Manufacturer Narrative
The complaint is unrefuted for unreturned vitality screw (pn: unk) for the failure of screw backed out postoperation.The products were not returned, and no photos were provided.Medical records were not provided for review.Potential cause: root cause can't be established, since the products were not returned.Dhr review and related actions: lot numbers were not provided, therefore dhr review can't be reviewed.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference report 3012447612-2020-00613-1.
 
Event Description
It was reported a closure top backed out of a pedicle screw post-operatively.No further information has been provided.This is report two of two for this event.
 
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Brand Name
PEDICLE SCREW, UNKNOWN TYPE OR SIZE
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10681134
MDR Text Key213698529
Report Number3012447612-2020-00614
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K150896
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 03/10/2021
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/16/2020
Initial Date FDA Received10/14/2020
Supplement Dates Manufacturer Received02/17/2021
Supplement Dates FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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