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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. UNKNOWN 40MM ROD

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ZIMMER BIOMET SPINE INC. UNKNOWN 40MM ROD Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problems Nerve Damage (1979); Pain (1994); Paralysis (1997); Brain Injury (2219); Stenosis (2263); Spinal Cord Injury (2432); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Udi number: na. 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 3012447612-2018-00890 thru 3012447612-2018-00895.
 
Event Description
It was reported that a nonunion developed post-operatively. The spacer was described as being crushed, has severed two nerve roots, and has affected the patient's brain. The rod was reported to be impinging upon the spinal chord. There are no current plans for revision. This is report four of six for this event.
 
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. The labeling was reviewed; non-union, pain, nerve damage, and changes in mental status are known possible complications associated with device usage.
 
Event Description
It was reported that a non-union developed post-operatively. The spacer was described as being crushed, has severed two nerve roots, and has affected the patient's brain. The rod was reported to be impinging upon the spinal chord. There are no current plans for revision. This is reported four of six for this event.
 
Manufacturer Narrative
Additional information: 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. Mdr mw5080740.
 
Event Description
It was reported that a nonunion developed post-operatively. The spacer was described as being crushed, has severed two nerve roots, and has affected the patient's brain. The rod was reported to be impinging upon the spinal chord. There are no current plans for revision. This is report four of six for this event.
 
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Brand NameUNKNOWN 40MM ROD
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 Key8039993
MDR Text Key126217786
Report Number3012447612-2018-00893
Device Sequence Number1
Product Code HSB
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,Followup,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
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
Date Manufacturer Received04/26/2022
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

Patient Treatment Data
Date Received: 11/05/2018 Patient Sequence Number: 1
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