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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
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ZIMMER BIOMET SPINE INC. PLUG; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Back to Search Results
Catalog Number 2000-1005
Device Problem Migration (4003)
Patient Problems Death (1802); Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
Event Date 07/01/2020
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 3012447612-2020-00376 to 3012447612-2020-00391.
 
Event Description
It was reported that a patient underwent a revision surgery after experiencing postoperative pain and discomfort.Sixteen plugs were found to have migrated, they were removed and replaced with alternates to complete the case.There were no additional patient impacts reported.This is report twelve of sixteen.
 
Manufacturer Narrative
Additional information: b2, b5, b7, d10, e1 (middle name),h1, h3, h6 (patient and method codes) 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 a patient underwent a revision surgery after experiencing postoperative pain and discomfort.Sixteen plugs were found to have migrated, they were removed and replaced with alternates to complete the case.There were no additional patient impacts reported.Additional information was provided which stated the patient has passed away due to covid-19 and it is not believed that the polaris construct contributed to the patient¿s passing.This is report twelve of sixteen.
 
Manufacturer Narrative
Correction to h1.Additional information: b5, h6 (patient code).
 
Event Description
A subsequent additional update was reported stating that the patient has not passed away but was admitted to the er for a l5 pedicle fracture and vertebral body fracture and was reported to be bedridden.No procedures have been scheduled, and the most recently received update was that the patient was discharged from the hospital.
 
Event Description
It was reported that a patient underwent a revision surgery after experiencing postoperative pain and discomfort.Sixteen plugs were found to have migrated, they were removed and replaced with alternates to complete the case.There were no additional patient impacts reported associated with this event.This is report twelve of sixteen.
 
Manufacturer Narrative
The complaint is confirmed for sixteen returned polaris closure tops for the failure of loosening due to screw fracture/ disassembly from improper use.Medical records were not provided for review.Device evaluation: visual inspection: the 15 of the 16 closure tops were returned to westminster for evaluation.The identities of the device were confirmed for those originally reported with 11 unknown lot numbers and 4 known lot numbers.All closures tops had the underside ring deformed and discolored and the pointed center dot featured flattened, indicating proper tightening to the rod.There are slight cosmetic wear marks on the sides, but otherwise no visible damage on the threads or elsewhere on the closure tops aside from slide wear from implantation and explantation.Functional test: all 15 returned closure tops were successfully tightened down to a test in a sawbone apparatus with a test bent using a polaris plug starter.Potential cause root cause was unable to be determined.This event could possibly be attributed to screw damage due to use with an spf device.Dhr review and related actions the dhr was reviewed, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.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
PLUG
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 Key10338177
MDR Text Key200792755
Report Number3012447612-2020-00387
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 distributor,health profession
Type of Report Initial,Followup,Followup,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2000-1005
Device Lot NumberJ6715776
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Other; Required Intervention;
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