MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; LAMINECTOMY PACK

Catalog Number DYNJ17452M

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that during a surgical procedure, the radiopaque strip detached from the neuro sponge.The surgeon located the strip in the surgical site and removed it.No irrigation was used to remove it.No patient injury resulted from this incident.The sample was not returned for evaluation.No photos were sent.A root cause has not been determined.

Event Description

The radiopaque strip detached from the sponge and fell into the surgical site.

• Type of Device: LAMINECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5858429
• MDR Text Key: 51692236
• Report Number: 1423395-2016-00045
• Device Sequence Number: 1
• Product Code: LRO
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ17452M
• Device Lot Number: 16CD1887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2016
• 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