MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP SPINE PACK

Catalog Number DYNJ901513D

Device Problems Flaked (1246); Output Problem (3005)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

It was reported that during an unknown surgery the neuro strips were being used and once they became saturated, they began to flake off inside of the patient.The surgeon would remove the material with forceps, irrigation or suction.No additional information is available.

Manufacturer Narrative

It was reported that during an unknown surgery the neuro strips were being used and once they became saturated, they began to flake off inside of the patient.The surgeon would remove the material from the patient with forceps, irrigation or suction.There was no report of any adverse patient consequence, no effect on the patient's stability, and no additional medical intervention required as a result of the incident.There was no reported impact to the patient, or the procedure being performed.The samples were returned to the manufacturer and the customer reported issue of flaking material was confirmed however no definitive root cause could be determined 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.

• Brand Name: SPINE PACK
• Type of Device: SPINE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14220118
• MDR Text Key: 299286948
• Report Number: 1423395-2022-00016
• Device Sequence Number: 1
• Product Code: OJH
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ901513D
• Device Lot Number: 21LBL398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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