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

Model Number	24-023-09-91
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	03/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two related mdrs.Please refer to mdr 9610905-2016-00012.
Event or Problem Description
The screws were used to fixate a plate as a surgical intervention to a rib fracture.They were removed on the following day due to patient's cough causing the screws to pull out.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was sent back for evaluation.It is determined that the complaint percentage falls well within the product risk limits that are adhered to at klm.The material and device history records were reviewed based on the lot number provided and no abnormalities were detected.Due to no device being returned the root cause for the failure cannot be determined.If further information can be gathered that might add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: THORACIC SCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 5627215
• Report Number: 9610905-2016-00013
• Device Sequence Number: 20089
• Product Code: HRS
• UDI-Device Identifier: 00888118031600
• UDI-Public: (01)00888118031600
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2016

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: 24-023-09-91
• Device Lot Number: 32782639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2016
• Supplement Report FDA Received Date: 07/25/2016
• 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: 55 YR