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

Model Number	8428-46-S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: CORTEX SCREW, 3.5MM X 46MM, T15, FLEX-THREAD¿
• Common Device Name: NON-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 Key: 12861935
• Report Number: 3009996260-2021-00016
• Device Sequence Number: 11841621
• Product Code: HSB
• UDI-Device Identifier: 00840118117289
• UDI-Public: 00840118117289
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K202858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8428-46-S
• Device Catalogue Number: 8428-46-S
• Device Lot Number: 2106321883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American