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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN SHOULDER NON-LOCKING SCREW
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UNKNOWN SHOULDER NON-LOCKING SCREW Back to Search Results
Catalog Number UNK SHOULDER N-L SCREW
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/13/2021
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
It was reported that reverse shoulder removed due to infection.Doi: unknown dor: (b)(6) 2021 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.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN SHOULDER NON-LOCKING SCREW
Type of Device
SHOULDER NON-LOCKING SCREW
MDR Report Key12704647
MDR Text Key278576517
Report Number1818910-2021-23685
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 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER N-L SCREW
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNKNOWN SHOULDER GLENOSPHERE; UNKNOWN SHOULDER HUMERAL CUP; UNKNOWN SHOULDER HUMERAL STEMS; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNKNOWN SHOULDER GLENOSPHERE; UNKNOWN SHOULDER HUMERAL CUP; UNKNOWN SHOULDER HUMERAL STEMS; 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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