MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE THORACIC; SCREW

Model Number	24-016-07-74
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Possible lot numbers for this device are 33210597 and 33211877.Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00013.
Event or Problem Description
It was reported that screws pulled out of the bone in a patient with pre-operative bone sarcoma.Review of the ct scans show that the lower rib that was plated was not reduced to bone-to-bone contact.The plate on this same rib was not contoured to align on the rib completely.This resulted in screws not being fully inserted into bone.The screws that were inserted were placed in the inferior border resulting in sub-optimal fixation.Ifu (b)(4) states the following are contraindications "patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections.".
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The product device history records were also reviewed based on the lot number provided, and no anomalies were found.The root cause for the failure cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7309533
• Report Number: 9610905-2018-00011
• Device Sequence Number: 16453317
• Product Code: HRS
• UDI-Device Identifier: 10888118011364
• UDI-Public: (01)10888118011364
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018
• Report Date (Section F): 02/05/2018

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: Physician
• Device Model Number: 24-016-07-74
• Device Lot Number: UNKNOWN - SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 03/19/2018
• 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: Other
• Patient Age: 56 YR