MAUDE Adverse Event Report: Integra LifeSciences Mansfield GERZOG MALLET 7-1/2 LEAD; Instruments - Ortho & Chiro

Catalog Number	19-790
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon reported that the gerzog mallet 7-1/2 lead (19-790) had pitting occurring on both ends upon using it during si bone fusion surgery.Both striking ends of the mallet appeared to be soft and able to make indentations with a fingernail.Prior to use, the surface of the mallet was smooth and free of any defects.The instrument was in direct contact with procedural pins utilized to make space in the patient's bone for the fusion device to be implanted.It is possible that part of the mallet came in contact with the patient within the surgical site.There is also a concern regarding the risk of flaking/particles from the mallet, which could have entered the surgical site, posing a potential risk for infection or retained particles.Additional information provided states, 'particles were not noticed on the surface, would not be able to see beyond surface level deeper into the surgical incision.Looking at the mallet, there appear to be areas with "chunks" missing, as well as surface indentations visible.The patient continues to have pain and denies any symptoms of infection.' there was no injury, death, or surgical delay reported during the procedure.
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.

• Brand Name: GERZOG MALLET 7-1/2 LEAD
• Common Device Name: Instruments - Ortho & Chiro
• 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 ; +1(609)936-2319
• MDR Report Key: 50114268
• Report Number: 3014334038-2026-00060
• Device Sequence Number: 20160082
• Product Code: HXL
• UDI-Device Identifier: 10381780420941
• UDI-Public: 10381780420941
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 19-790
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 30 YR
• Patient Sex: Female