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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW25MM; BONE SCREWS AND PINS : SCREWS
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DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW25MM; BONE SCREWS AND PINS : SCREWS Back to Search Results
Model Number 1011-40-025
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 02/18/2021
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 the patient broke the protrusio cage and a few screws implanted back in 2019.Surgeon removed all cage and screws along with a cemented cup and replaced with a pinnacle revision cup and used dual mobility to help patient with stability.No surgical delay.Doi:(b)(6) 2019, dor: (b)(6) 2021, left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
 
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Brand Name
SLF TAPPING ROOF PILE SCRW25MM
Type of Device
BONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11436238
MDR Text Key238372208
Report Number1818910-2021-04586
Device Sequence Number1
Product Code JDJ
UDI-Device Identifier10603295000433
UDI-Public10603295000433
Combination Product (y/n)N
PMA/PMN Number
K962007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1011-40-025
Device Catalogue Number101140025
Device Lot NumberJ30C31
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTICUL/EZE BALL 32 +5 BR; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PROSTALAC ACET CUP 42X32; PROTRUSIO CAGE 52OD X 49ID L; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW20MM; SLF TAPPING ROOF PILE SCRW35MM; UNKNOWN BONE CEMENT; ARTICUL/EZE BALL 32 +5 BR; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PROSTALAC ACET CUP 42X32; PROTRUSIO CAGE 52OD X 49ID L; SLF TAPPING ROOF PILE SCRW15MM; SLF TAPPING ROOF PILE SCRW20MM; SLF TAPPING ROOF PILE SCRW35MM; UNKNOWN BONE CEMENT
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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