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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PALACOS RG 1X40 SINGLE; BONE CEMENT, ANTIBIOTIC
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ZIMMER SURGICAL, INC. PALACOS RG 1X40 SINGLE; BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.
 
Event Description
It was reported that when transferring the powder onto a sterile field, the unsterile packaging tore and compromised the sterile powder.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.
 
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Brand Name
PALACOS RG 1X40 SINGLE
Type of Device
BONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
MDR Report Key6971116
MDR Text Key90843366
Report Number0001526350-2017-00786
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00111314001
Device Lot Number86434597
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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