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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.B.M. SAS SELF-LOCKING SCREW OTIS-LENGTH 60 MM; METALLIC BONE FIXATION SCREW

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S.B.M. SAS SELF-LOCKING SCREW OTIS-LENGTH 60 MM; METALLIC BONE FIXATION SCREW Back to Search Results
Catalog Number EVO9066060
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
For regularization - retrospective review / fda request.Following the analysis of the bags, the weld is compliant.The opening of the first peelable bag can be observed intentionally: there are white marks where the bags are separated for opening.These marks are only present when the welding has been done.The quality of the weld is not questioned: the welding has taken place and in accordance.No corrective action taken: the anomaly is not due to a welding defect or any quality problem with the product.
 
Event Description
Fnc (b)(4) - for regularization - retrospective review / fda request."otis screw box opened and not used because one of the sterile double peelable bags was poorly welded and open".
 
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Brand Name
SELF-LOCKING SCREW OTIS-LENGTH 60 MM
Type of Device
METALLIC BONE FIXATION SCREW
Manufacturer (Section D)
S.B.M. SAS
zi du monge
lourdes, france 65100
FR  65100
Manufacturer (Section G)
S.B.M. SAS
zi du monge
lourdes, france 65100
FR   65100
Manufacturer Contact
regine bareilles
zi du monge
lourdes, france 65100
FR   65100
MDR Report Key8639440
MDR Text Key146358560
Report Number3004549189-2019-00083
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K120808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/05/2019
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 Date12/19/2017
Device Catalogue NumberEVO9066060
Device Lot Number123301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/23/2013
Initial Date FDA Received05/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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