MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PRAIRE STAR SPINE CDS

Catalog Number CDS984227

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a lumbar decompression the sponge shed lint into the surgical site.Linting was discovered in the middle of the procedure.The surgeon was able to remove the linted material from the surgical site via an unknown method.No serious injury or follow-up care was reported.No impact to the patient or to the procedure was reported.No sample was returned to the manufacturer for evaluation.Due to the need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during a lumbar decompression the sponge shed lint into the surgical site.

• Type of Device: PRAIRE STAR SPINE CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfiedl, IL 60093 ; 2249311458
• MDR Report Key: 7352100
• MDR Text Key: 103276866
• Report Number: 1423395-2018-00012
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10884389762998
• UDI-Public: 10884389762998
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CDS984227
• Device Lot Number: 17VB8072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention