MAUDE Adverse Event Report: INTEGRA LIFESCIENCES; NEURO SPONGE IN SPINE-ROH TRAY

Catalog Number DYNJ903293L

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

It was initially reported that the neuro sponge (taken from custom surgical tray) split in half and was unable to be retrieved.Upon follow-up, it was reported, "it was decided this was an operator error and not a product defect." despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.Due to the reported retained neuro sponge, this medwatch is being filed.A notification to the manufacturer of the neuro sponge involved in this incident has been done.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that an operator error resulted in the neuro sponge splitting in half.The neuro sponge was reportedly unable to be retrieved.

• Type of Device: NEURO SPONGE IN SPINE-ROH TRAY
• Manufacturer (Section D): INTEGRA LIFESCIENCES; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9334964
• MDR Text Key: 166782995
• Report Number: 1423395-2019-00047
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ903293L
• Device Lot Number: 19GDA654
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other