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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW40MM; BONE SCREWS AND PINS : SCREWS
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DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW40MM; BONE SCREWS AND PINS : SCREWS Back to Search Results
Model Number 1011-40-040
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 07/14/2020
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
It was reported that patient presented to doctor's office with pain.Xrays showed possible loosening of protrusio cage.Surgery scheduled and dr.(b)(6) found cage loose.Removed head, liner and cage and reinsert a multi hole grip cup, liner and head.Doi: (b)(6) 2017, dor: (b)(6) 2020, affected side: right 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.
 
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Brand Name
SLF TAPPING ROOF PILE SCRW40MM
Type of Device
BONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10312228
MDR Text Key200004467
Report Number1818910-2020-16664
Device Sequence Number1
Product Code JDJ
UDI-Device Identifier10603295000464
UDI-Public10603295000464
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 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1011-40-040
Device Catalogue Number101140040
Device Lot Number736988
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARTICULEZE M HEAD 36MM +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR +4 NEUT 36IDX58OD; PROTRUSIO CAGE 64ODX61ID R; SLF TAPPING ROOF PILE SCRW30MM; SLF TAPPING ROOF PILE SCRW35MM; SLF TAPPING ROOF PILE SCRW35MM; SLF TAPPING ROOF PILE SCRW40MM; SLF TAPPING ROOF PILE SCRW40MM; ARTICULEZE M HEAD 36MM +8.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR +4 NEUT 36IDX58OD; PROTRUSIO CAGE 64ODX61ID R; SLF TAPPING ROOF PILE SCRW30MM; SLF TAPPING ROOF PILE SCRW35MM; SLF TAPPING ROOF PILE SCRW35MM; SLF TAPPING ROOF PILE SCRW40MM; SLF TAPPING ROOF PILE SCRW40MM
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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