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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SHARP KERRISON TIP RONGEUR TIP

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SYMMETRY SURGICAL INC. SYMMETRY SHARP KERRISON TIP RONGEUR TIP Back to Search Results
Model Number 53-1661
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Event Description
During the acdf (anterior cervical discectomy and fusion), the symmetry sharp kerrison tip broke off. The surgeon ordered an x-ray. The symmetry sharp kerrison tip could not be identified in the x-ray. The symmetry sharp kerrison tip could not be found in the surgical field. The patient was sent to recovery in stable condition. No untoward effects.
 
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Brand NameSYMMETRY SHARP KERRISON TIP
Type of DeviceRONGEUR TIP
Manufacturer (Section D)
SYMMETRY SURGICAL INC.
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL INC.
3034 owen drive
antioch TN 37013
Manufacturer Contact
victoria rogers
3034 owen drive
antioch, TN 37013
8002513000
MDR Report Key7807021
MDR Text Key118115775
Report Number3007208013-2018-00015
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1661
Device Catalogue Number53-1661
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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