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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE INC. ARRAY SET SCREW, UNKNOWN TYPE EBI ARRAY SPINAL SYSTEM Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problem Inadequate Osseointegration (2646)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
There were no reports of device malfunction, however the manufacturer found the set screw had backed out of the mating screw when reviewing the provided x-ray. The cause cannot be determined with the available information. But, this event could possibly be attributed to the fusion not healing properly, as stated by the complainant. The lot number is unknown, so the dhr is unable to be reviewed. This device is used for treatment. If any information is received which changes the information in the report, a follow-up report will be submitted. Reference reports 3012447612-2021-00169-1, 3012447612-2021-00170-1, and 3012447612-2021-00223.
 
Event Description
It was reported that two screws broke at s1 bilaterally after being implanted for approximately 17 years. A revision surgery was performed, however, the surgeon was unable to get the proper angle to remove the screws so left them implanted. The adjacent level was added to the construct. X-ray evaluation by the manufacturer found two set screws had also backed out. The set screws were retightened in the screws during the revision surgery. This is report three of four for this event.
 
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Brand NameARRAY SET SCREW, UNKNOWN TYPE
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 Key12069645
MDR Text Key258478099
Report Number3012447612-2021-00222
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
Report Date 06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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

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