MAUDE Adverse Event Report: TAYLOR GROVE-KLS / KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG KLS 2.0X13MM SCREW; PLATE, BONE

Model Number 25-872-13-91

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Surgeon was performing a very complicated orif of mandibular fractures.Many screws and plates were inserted and removed trying to find the proper fusion for this pt.One of the screw heads broke off, but the threading remained in the pt's mandibular.The screw was a kls 2.0x13mm crew with ref number: 25-872-13-91.The dr was satisfied with the fixation that it provided, and decided that it would cause more harm trying to retrieve it, than for it to remain.The screw head was retrieved from the mouth and placed in the sharps container.Both the surgeon and scrub tech confirmed that it was out of the pt.Fda safety report id# (b)(4).

• Brand Name: KLS 2.0X13MM SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): TAYLOR GROVE-KLS / KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
• MDR Report Key: 9591691
• MDR Text Key: 175480645
• Report Number: MW5092237
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 25-872-13-91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR