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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLATE, UNKNOWN TYPE

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ZIMMER BIOMET SPINE INC. PLATE, UNKNOWN TYPE Back to Search Results
Device Problems Flaked (1246); Biocompatibility (2886)
Patient Problems Pain (1994); Reaction (2414)
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 3012447612-2018-00954 thru 3012447612-2018-00971. Mw5080455.
 
Event Description
It was reported that a patient has experienced a metal allergy, implant metal flaking, and pain post-operatively. The construct remains implanted. This is report fourteen of eighteen for this event.
 
Manufacturer Narrative
Additional information: results and conclusions - the complaint eludes to the polaris 5. 5 product system being used, but this system does not contain any plates. It is possible that the polaris cross-connectors are actually being referenced, but this cannot be determined without further information. The plate (or cross-connector) was not returned and the device's identity is not available, so an evaluation is unable to be performed. The components of all polaris 5. 5 cross-connectors are made of titanium. Since the device identity is unknown, the dhr is unable to be reviewed and there are no clear indications that this device may have contributed to the alleged event. The root cause is unable to be determined with the available information.
 
Event Description
It was reported that a patient has experienced a metal allergy, implant metal flaking, and pain post-operatively. The construct remains implanted. This is report fourteen of eighteen for this event.
 
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Brand NamePLATE, UNKNOWN TYPE
Type of DeviceUNKNOWN
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8111711
MDR Text Key128632816
Report Number3012447612-2018-00967
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/17/2019
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

Patient Treatment Data
Date Received: 11/28/2018 Patient Sequence Number: 1
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