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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 85/80 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 85/80 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71642685
Device Problems Device Markings/Labelling Problem (2911); Unintended Movement (3026)
Patient Problems Respiratory Tract Infection (2420); Implant Pain (4561)
Event Date 04/10/2021
Event Type  Injury  
Event Description
It was reported that after trauma procedure for internal hip fixation, the patient had postoperative pain on the hip joint, copd exacerbation and lung infection. X-ray examination indicated good positioning of the implant. Two days after the procedure, it was discovered that trigen meta-tan troch antegr nail screws were use to fixate a trigen intertan intertroch antegr nail, causing the implant to be unstable. A revision surgery had to be performed in order to retrieve the wrong screws and insert the correct ones. Details about the surgery are unknown. No other complications were reported.
 
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Brand NameMETA-TAN LAG/COMP KIT 85/80
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key11815676
MDR Text Key250323557
Report Number1020279-2021-04118
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K092748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71642685
Device Catalogue Number71642685
Device Lot Number18LT12507
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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