MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DYNAMIC DISC, NITINOL, REFLEXTM, 7.0MM

Catalog Number MSWN3000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 during a procedure 'when tightening the screw, an audible pop was heard and the cannulated screw passed through the disc and the physician had to fish out the disc from the patient'.Per the facility the surgeon moved on without the disc and there was no impact to the patient, and the procedure was completed without further issue.The device is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2022 during a procedure 'when tightening the screw, an audible pop was heard and the cannulated screw passed through the disc and the physician had to fish out the disc from the patient'.

• Type of Device: DYNAMIC DISC, NITINOL, REFLEXTM, 7.0MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15411540
• MDR Text Key: 299789925
• Report Number: 1417592-2022-00163
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MSWN3000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 86 KG