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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUP MED CLAV LK PL 10H L 121MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. SUP MED CLAV LK PL 10H L 121MM PLATE, FIXATION, BONE Back to Search Results
Model Number 71823402
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369)
Event Date 03/29/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that the patient underwent surgery on (b)(6) 2021 for a clavicle fracture. On (b)(6) 2022 at night, while sleeping, he felt a click and pain in the left clavicle, he went to the consultation due to pain and, under confirmation with x-rays, there was fracture on the sup med clav lk pl 10h l 121mm. The patient was re-operated on (b)(6) 2022 to extract broken material and new osteosynthesis with a competitor device. The patient's current status is stable.
 
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Brand NameSUP MED CLAV LK PL 10H L 121MM
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 Key14282797
MDR Text Key290699913
Report Number1020279-2022-02120
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K061352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71823402
Device Catalogue Number71823402
Device Lot Number18JM18994
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2018
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: 05/04/2022 Patient Sequence Number: 1
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