MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG SONICWELD RX; SONICPIN

Model Number 52-516-54-04

Device Problems Off-Label Use (1494); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported resorbable pins used off-label to affix a titanium distractor footplate pulled loose from the footplate, necessitating removal and replacement of the pins with titanium screws.

Manufacturer Narrative

Lot numbers: 33388735, 33405992.

• Brand Name: SONICWELD RX
• Type of Device: SONICPIN
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN L.P.; p.o. box 16369; jacksonville FL 32245
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 12964190
• MDR Text Key: 281973208
• Report Number: 9610905-2021-00112
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10888118001044
• UDI-Public: (01)10888118001044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080862
• Exemption Number: 2017029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 52-516-54-04
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 MO
• Patient Sex: Female