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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CANNULATED SCREWS SCREW PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKN CANNULATED SCREWS SCREW PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNKNOWN
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Zhu, z. D. , xiao, c. W. , tan, b. , tang, x. M. , wei, d. , yuan, j. B. , & feng, l. (2021). Tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients. Orthopaedic surgery, 13(1), 244-252. Doi: 10. 1111/os. 12915.
 
Event Description
On the literature article named "tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients", it was reported that, after cannulated screws screw had been implanted on 1 patient, after conventional internal fixation surgery using three 7. 3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, one patient had a screw which began slipping and migrating from its original position. This was noticed 3 months postoperatively. 12 months postoperatively, the femoral head was displaced again. Further details on how was this adverse event treated are unknown.
 
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Brand NameUNKN CANNULATED SCREWS SCREW
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 Key12624528
MDR Text Key276165035
Report Number1020279-2021-07557
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? No
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: 10/13/2021 Patient Sequence Number: 1
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