MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG RESORB X; PLATE

Model Number	52-310-14-04
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is related to 9610905-2017-00023.Both mdr's are submitted for the same patient and event however due to two different devices involved separate mdr's are being filed.It is unknown the exact date swelling began therefore event date could not be determined.Product from this patient was returned, however due to product degradation it is unknown which product was returned.
Event or Problem Description
Patient developed sores and significant swelling 4-9 months post-operative directly over implants.Doctor indicated that this was not the normal inflammatory response.
Additional Manufacturer Narrative
During the investigation chemical, sterility and viscosity testing was performed on samples from the same stock and lot.The chemical composition, sterility, and viscosity was tested and revealed no anomalies.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 anomalies detected.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: RESORB X
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6335622
• Report Number: 9610905-2017-00011
• Device Sequence Number: 11154183
• Product Code: JEY
• UDI-Device Identifier: 00888118000774
• UDI-Public: (01)00888118000774
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 52-310-14-04
• Device Lot Number: 32810983
• 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: 01/17/2017
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 1 YR