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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.4MM Y-PLATE 5 HOLE HD 7 HOLE SFT PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. EVOS 2.4MM Y-PLATE 5 HOLE HD 7 HOLE SFT PLATE, FIXATION, BONE Back to Search Results
Model Number 72442484N
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Insufficient Information (4580)
Event Date 02/25/2022
Event Type  Injury  
Event Description
It was reported that, after an internal fixation surgery, the evos 2. 4mm y-plate 5 hole head 7 hole shaft fractured. It is unknown how this situation was resolved, as well as the current health status of the patient.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameEVOS 2.4MM Y-PLATE 5 HOLE HD 7 HOLE SFT
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14605077
MDR Text Key293432247
Report Number1020279-2022-02753
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K082516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/19/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72442484N
Device Catalogue Number72442484N
Device Lot Number21JM17849
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2022 Patient Sequence Number: 1
Treatment
PERI-LOC 4.5MM T25 LOCK SCREW 30MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 74MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 80MM S-T
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