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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC
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BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R-3; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 4711500396-3
Device Problem Improper Chemical Reaction (2952)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed the review of the device manufacturing quality record indicate that 1872 products optipac 60 refobacin bone cement r, reference 4711500396-3, batch 910aa06885 were manufactured on (april 16, 2019).The device manufacturing quality record 6536831 indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue (complaint category cement too long seeting time) event described in the complaint.With the available information, the exact root cause of the event could not be determined.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
 
Event Description
It was reported that the cement was stored in the usual storage conditions and taken to the operating room under the regular procedure.6 minutes after the mixing was completed, the cement was fully cured which is a short time.The surgeon did not have time to fix the implants, so another cement and new implants were used without any further problems.There was no patient impact.
 
Event Description
It was reported that the cement was stored in the usual storage conditions and taken to the operating room under the regular procedure.6 minutes after the mixing was completed, the cement was fully cured which is a short time.The surgeon did not have time to fix the implants, so another cement and new implants were used without any further problems.There was no patient impact.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore it will not be analyzed.The review of the device manufacturing quality record indicate that (b)(4) products optipac 60 refobacin bone cement r, reference 4711500396-3, batch 910aa06885 were manufactured on (april 16, 2019).The device manufacturing quality record 6536831 indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue (complaint category cement too long seeting time) event described in the complaint.The current complaint is the only recorded over the batch 910aa06885 within one year.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
 
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Brand Name
OPTIPAC 60 REFOBACIN BONE CEMENT R-3
Type of Device
BONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR  26903
MDR Report Key9202070
MDR Text Key216685163
Report Number3006946279-2019-00419
Device Sequence Number1
Product Code MBB
UDI-Device Identifier04040029922361
UDI-Public(01)04040029922361
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue Number4711500396-3
Device Lot Number910AA06885
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/27/2019
Initial Date FDA Received10/17/2019
Supplement Dates Manufacturer Received03/02/2020
Supplement Dates FDA Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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