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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS CORTEX SCREW, 3.5MM X 46MM, T15, FLEX-THREAD¿ NON-LOCKING BONE SCREW

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CONVENTUS FLOWER ORTHOPEDICS CORTEX SCREW, 3.5MM X 46MM, T15, FLEX-THREAD¿ NON-LOCKING BONE SCREW Back to Search Results
Model Number 8428-46-S
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  Injury  
Manufacturer Narrative
Dr. (b)(6) first drilled longer path lengths for screw insertion, as he had planned to insert longer screws. After determining that these screws were too long, he decided to implant shorter screws in the same hole.
 
Event Description
The event included the backing out of two non-locking cortex screws, which was discovered using x-ray 26 days post-implantation. A revision surgery is scheduled to be performed on (b)(6) 2021. This event is associated with the same patient and surgical procedure as described in mdr 3009996260-2021-00015.
 
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Brand NameCORTEX SCREW, 3.5MM X 46MM, T15, FLEX-THREAD¿
Type of DeviceNON-LOCKING BONE SCREW
Manufacturer (Section D)
CONVENTUS FLOWER ORTHOPEDICS
100 witmer rd.
ste 280
horsham PA 19044
Manufacturer (Section G)
ODYSSEY MEDICAL TECHNOLOGIES (CONTRACT MANUFAC.)
2975 brother blvd
barlett TN 38133
Manufacturer Contact
amanda pentecost
100 witmer rd.
ste 280
horsham, PA 19044
2153234029
MDR Report Key12861935
MDR Text Key281153382
Report Number3009996260-2021-00016
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8428-46-S
Device Catalogue Number8428-46-S
Device Lot Number2106321883
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2021
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: 11/23/2021 Patient Sequence Number: 1
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