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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PICASSO II; ROD
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CTL MEDICAL CORPORATION PICASSO II; ROD Back to Search Results
Catalog Number 016.3110
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Event Description
6.0 diameter and 110mm mis rod was inserted using a rod inserter into mis tulip heads to complete mis construct.End user applied pressure to set and final position the rod, causing the proximal tip that was held inside the rod inserter seperate from the distal rod shaft.The subject rod function as a bridge that passes through the skin and sits into multiple spacially aligned bone-anchored screw housings.Excessive pressure for rod insertion into a housing by an end-user tentatively points to a questionable placement of screws, degree of patient anatomy, and/or user technique.No images, parts, patient anatomy, or detailed user steps were provided.No harm or injury to the patient is reported but a minor 5 minute delay.Without additional evidence(s), this claim is indeterminate.
 
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Brand Name
PICASSO II
Type of Device
ROD
Manufacturer (Section D)
CTL MEDICAL CORPORATION
4550 excel parkway
addison TX 75001
Manufacturer (Section G)
CTL MEDICAL CORPORATION
4550 excel parkway
addison TX 75001
Manufacturer Contact
tracy bui
4550 excel parkway
addison, TX 75001
MDR Report Key15905630
MDR Text Key307805856
Report Number3009051471-2022-00013
Device Sequence Number1
Product Code JDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number016.3110
Device Lot Number15A5.WBBA
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
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