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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL EXTENDED TAB SCREW 7.5X45MM; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL EXTENDED TAB SCREW 7.5X45MM; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 810M7545
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/28/2020
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 3012447612-2020-00208 to 3012447612-2020-00211.
 
Event Description
It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.This is report four of four for this event.
 
Manufacturer Narrative
Additional information in h6: method, results, and conclusions.The device was not returned for evaluation, however, x-rays were provided but are insufficient to detect any malfunctions associated with the screw.Since the device was unable to be evaluated, there are no results available and the cause cannot be determined.The dhr was unable to be reviewed since the lot number is unknown.The labeling was reviewed and found to contain instructions regarding proper device usage.This device falls within the scope of field action 3012447612-05-01-2020-001-r; however, this event is not associated with the recall.
 
Event Description
It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery and removed the two screws.However, it was not stated that k-wires, retained in the pedicles, were able to be removed.This is report four of four for this event.
 
Event Description
It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery and removed the two screws.However, it was not stated that k-wires, retained in the pedicles, were able to be removed.This is report four of four for this event.
 
Manufacturer Narrative
Additional information in: a1, a2 (date of birth), a4, a5, b5, b7, and d7.
 
Event Description
It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery where the two screws and the tip of one of the guide wires were removed.This is report four of four for this event.
 
Manufacturer Narrative
This report is providing additional information received by the manufacturer.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.
 
Event Description
It was reported that during the procedure the k-wires were binding inside the pedicle screws during screw installation.The tips of two wires broke off and were retained within the pedicles of l5 and s1.There were no additional patient impacts reported.Additional information was provided stating that the patient underwent a revision surgery where the two screws and the tip of one of the guide wires were removed.This is report four of four for this event.
 
Manufacturer Narrative
The returned screw was evaluated.The threaded shaft tip was found to have fractured.The size of the cannula was found to meet specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.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.
 
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Brand Name
CANNULATED POLYAXIAL EXTENDED TAB SCREW 7.5X45MM
Type of Device
VITALITY SPINAL FIXATION SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10005777
MDR Text Key190480594
Report Number3012447612-2020-00211
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K183550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number810M7545
Device Lot NumberC19I0016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
Patient Weight93
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