MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD INSERTS FOR MOUTH GAG; INSTRUMENTS - SURGICAL

Catalog Number	450110RI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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
A facility reported the product inserts for mouth gag (450110ri) was torn, detached, and was from the elastic.It was reported that the surgeon completed the procedure.Upon removing the mouth gag, they noticed that one of the pins connecting the elastic to the mouth gag had torn/detached from the elastic and was missing.Their team conducted a search in the operating room and inside the patient¿s mouth, but the missing part was not found.The physician also examined the patient¿s oral cavity and did not find the missing pin.According to one of the teammates, it was impossible for the detached part to have passed through the suction.The patient was discharged home feeling well and with no complaints.There was no delay, injury, or death reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11 the inserts for mouth gag (450110ri) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The pieces were reportedly missing after the procedure, and it was unknown whether the items had been left in the patient.Definitive root cause cannot be determined.The issue of tearing may be the result of rough handling or environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: INSERTS FOR MOUTH GAG
• Common Device Name: INSTRUMENTS - SURGICAL
• 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: 24531202
• Report Number: 3014334038-2026-00019
• Device Sequence Number: 21418410
• Product Code: KBN
• UDI-Device Identifier: 10381780192701
• UDI-Public: 10381780192701
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 04/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 450110RI
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown