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

Model Number	24-015-25-71
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown exactly when the plates began to break therefore event date could not be determined.Return of the device is anticipated.An analysis will be completed upon receipt, and a follow up report will be submitted once investigation is complete.
Event or Problem Description
One month post-operation patient had a scan and all implanted plates looked fine.Patient came back to the hospital in (b)(6) 2016 for another procedure and it was discovered that one of the plates were broken.While she was inpatient for the other procedure the other two plates were reported to break.The broken plates were removed and replaced on (b)(6) 2017.It was reported the patient was a smoker up until the initial surgery.
Additional Manufacturer Narrative
The plates were kept by the hospital and are not available for analysis.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.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: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6335596
• Report Number: 9610905-2017-00007
• Device Sequence Number: 885657
• Product Code: HRS
• UDI-Device Identifier: 00888118092540
• UDI-Public: (01)00888118092540
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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: 24-015-25-71
• Device Lot Number: 33164233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 57 YR
• Patient Weight: 60