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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRAUMA PLATE AND SCREW INSTR; PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKN TRAUMA PLATE AND SCREW INSTR; PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNKN02500100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Deformity/ Disfigurement (2360); Physical Asymmetry (4573)
Event Date 02/24/2021
Event Type  Injury  
Event Description
It was reported that, after an intertan trauma surgery the patient healed, but wanted the unspecified screws out due to lateral prominence.A revision surgery was performed to address this event.The current status of patient¿s health is unknown.
 
Manufacturer Narrative
H3, h6: the devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of devices or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
UNKN TRAUMA PLATE AND SCREW INSTR
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11548671
MDR Text Key241674304
Report Number1020279-2021-02318
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKN02500100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/24/2021
Initial Date FDA Received03/23/2021
Supplement Dates Manufacturer Received03/15/2021
08/09/2021
Supplement Dates FDA Received04/14/2021
08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age60 YR
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