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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW
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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW Back to Search Results
Catalog Number UNK SHOULDER LOCKING SCREW
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
(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 to address instability.Doi: unknown, dor: (b)(6) 2020, unknown affected side.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
UNKNOWN SHOULDER LOCKING SCREW
Type of Device
UNKNOWN SHOULDER LOCKING SCREW
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10509845
MDR Text Key206195536
Report Number1818910-2020-19701
Device Sequence Number1
Product Code KWT
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER LOCKING SCREW
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND STAND PE CUP D42 +9MM; METAGLENE LONG PEG +15MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; XTND GLENO ECC D42MM +8MM; DXTEND STAND PE CUP D42 +9MM; METAGLENE LONG PEG +15MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; XTND GLENO ECC D42MM +8MM
Patient Outcome(s) Required Intervention;
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