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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ROD, UNKNOWN SIZE

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ZIMMER BIOMET SPINE INC. ROD, UNKNOWN SIZE Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Udi number: ni. 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 a revision surgery was performed to address a rod, which broke post-operatively. No further details are available.
 
Manufacturer Narrative
Additional information: results and conclusions - the device was not returned for evaluation so no results are available and no conclusions can be drawn. 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.
 
Event Description
It was reported that a revision surgery was performed to address a rod which broke post-operatively. No further details are available.
 
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Brand NameROD, UNKNOWN SIZE
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 Key8131273
MDR Text Key129383022
Report Number3012447612-2018-00974
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
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 Received05/01/2019
Was Device Evaluated by Manufacturer? No
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: 12/04/2018 Patient Sequence Number: 1
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