MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BULK SURG PAT 1 X 1; OEM PATTIES & STRIPS

Catalog Number	245407
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
Fda reference no.(b)(4).A facility reported a neuro patty (id 245407) was not x-ray detectable.The neuro sponge count was off.The doctor was notified and had to reopen the patient's surgical site to find the missing neuro sponge.The missing component was recovered, and the neuro sponge was later x-rayed, however, it did not show up.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The neuro patty (id 245407) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined, however, potential cause of the reported event may be related to a deficiency with the attached x-ray polymer strip.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.A corrective and preventative action (capa) was closed in (b)(6) 2022 for the patties/strips product family related to discoloration, incorrect count, string issues, and x-ray detectability.Actions were implemented to minimize the issue reported.

• Brand Name: BULK SURG PAT 1 X 1
• Common Device Name: OEM PATTIES & STRIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19893440
• Report Number: 3014334038-2024-00161
• Device Sequence Number: 7796337
• Product Code: HBA
• UDI-Device Identifier: 10381780513407
• UDI-Public: 10381780513407
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 245407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown