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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.); TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.); TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 00392500200
Device Problem Fracture (1260)
Patient Problems Weakness (2145); Brain Injury (2219); Alteration In Body Temperature (2682)
Event Date 09/18/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
 
Event Description
It was reported that during a procedure, the instrument fractured and damaged the patient's cauda equina.The patient was noted to have diminished strength.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.)
Type of Device
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8159257
MDR Text Key130165481
Report Number0001822565-2018-06901
Device Sequence Number1
Product Code HXZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00392500200
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/14/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received04/04/2019
Supplement Dates FDA Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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