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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL 10H L230MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL 10H L230MM PLATE, FIXATION, BONE Back to Search Results
Model Number 71820010
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, during surgery, a 4. 5mm l-d fem lk pl 10h l 230mm broke, it is unknown when the event happened (internal or external) or if there was any delay or injury. It is unknown if there was a s&n backup device available.
 
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Brand Name4.5MM L-D FEM LK PL 10H L230MM
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 Key14506036
MDR Text Key292808696
Report Number1020279-2022-02594
Device Sequence Number1
Product Code HRS
UDI-Device Identifier03596010527431
UDI-Public03596010527431
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K092015
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
Report Date 07/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71820010
Device Catalogue Number71820010
Device Lot Number21CM23774
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/26/2022 Patient Sequence Number: 1
Treatment
73826032 / PERI-LOC 4.5MM T25 CRTX SCREW 32MM S-T; 73826034 / PERI-LOC 4.5MM T25 CRTX SCREW 34MM S-T; 73827032 / PERI-LOC 4.5MM T25 LOCK SCREW 32MM S-T; 73827034 / PERI-LOC 4.5MM T25 LOCK SCREW 34MM S-T; 73827074 / PERI-LOC 4.5MM T25 LOCK SCREW 74MM S-T; 73827078 / PERI-LOC 4.5MM T25 LOCK SCREW 78MM S-T; 73827080 / PERI-LOC 4.5MM T25 LOCK SCREW 80MM S-T
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