MAUDE Adverse Event Report: BAAT MEDICAL PRODUCTS B.V. KLEINER KG2 SYSTEM; LUMBAR INTERVERTEBRAL FUSION DEVICE

Model Number	02-92213
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a customer reported an event that occurred with a kleiner kg2 cage.They had received a message from dr.(b)(6), a surgeon, on (b)(6) 2023 that a cage had partially backed out and that would need a revision surgery.The patient at some point (date unknown) after the initial surgery complained of recurring pain.Dr.(b)(6) took the patient back to the or and attempted to further impact the cage into the disc space.The patient subsequently returned at some point again complaining of recurring pain.A revision surgery is planned.
Additional Manufacturer Narrative
Migration is a know inherent risk of the device in is as such stated in the labelling as potential adverse event.The ifu states: the surgeon may need to perform additional surgery to address any complications or adverse reactions, which may or may not be device related.Potential risks identified with the use of this intervertebral body fusion device, which may require additional surgery include: cage migration or dislocation.

• Brand Name: KLEINER KG2 SYSTEM
• Common Device Name: LUMBAR INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): BAAT MEDICAL PRODUCTS B.V.; f. hazemeijerstraat 800; hemgelo, overijssel 7555 RJ; NL 7555 RJ
• Manufacturer (Section G): BAAT MEDICAL PRODUCT B.V.; f. hazemeijerstraat 800; hengelo, overijssel 7555 RJ; NL 7555 RJ
• Manufacturer Contact: jasper springer ; f. hazemeijerstraat 800; hengelo, overijssel 7555 -RJ ; NL 7555 RJ
• MDR Report Key: 16851535
• Report Number: 3015216945-2023-00001
• Device Sequence Number: 17835412
• Product Code: MAX
• UDI-Device Identifier: 08720246782486
• UDI-Public: (01)08720246782486(17)270523(10)22-0310(11)220524
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: 02-92213
• Device Catalogue Number: 02-92213
• Device Lot Number: 22-0310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female