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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. UNKNOWN ARRAY PEDICLE SCREW EBI ARRAY SPINAL SYSTEM

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ZIMMER BIOMET SPINE INC. UNKNOWN ARRAY PEDICLE SCREW EBI ARRAY SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Inadequate Osseointegration (2646)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
Reference report (b)(4). 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 that two screws broke at s1 bialaterally. Over time, the fusion did not heal properly which caused the screws to break. An adjacent level fusion was done. The two screws were left in the patient since the physician could not get a good angle on them. Two new screws were added and original caps were used to complete the case. This is report one of two for this event.
 
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Brand NameUNKNOWN ARRAY PEDICLE SCREW
Type of DeviceEBI ARRAY SPINAL 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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key11815434
MDR Text Key250362489
Report Number3012447612-2021-00169
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061563
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 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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