MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS CORTEX SCREW, 3.5MM X 44MM, T15, FLEX-THREAD¿; NON-LOCKING BONE SCREW

Model Number 8428-44-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  

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 3009996260-2021-00016.

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.

• Brand Name: CORTEX SCREW, 3.5MM X 44MM, T15, FLEX-THREAD¿
• Type of Device: 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: 12861887
• MDR Text Key: 281154936
• Report Number: 3009996260-2021-00015
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00840118117272
• UDI-Public: 00840118117272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8428-44-S
• Device Catalogue Number: 8428-44-S
• Device Lot Number: 2106321847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American