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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER LOCKING SCREW
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DEPUY FRANCE SAS - 3003895575 UNKNOWN SHOULDER LOCKING SCREW Back to Search Results
Catalog Number UNK SHOULDER LOCK SCREW
Device Problem Osseointegration Problem (3003)
Patient Problems Pain (1994); Inadequate Osseointegration (2646)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The patient was revised for pain and loosening of the glenoid at the bone to implant interface.Doi: 2012, dor: (b)(6) 2020, right shoulder.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNKNOWN SHOULDER LOCKING SCREW
Type of Device
SHOULDER LOCKING SCREW
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key10980493
MDR Text Key220640097
Report Number1818910-2020-26675
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER LOCK SCREW
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
38MM GLENOSPHERE; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; 38MM GLENOSPHERE; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
Patient Outcome(s) Required Intervention;
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