MAUDE Adverse Event Report: ULRICH GMBH & CO. KG ADD/SMALL VBR; ADD/SMALL VBR, 14MM, HEIGHT 16-25MM, ANGLE 0

Model Number	CS 2250-14-16
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer) exemption # e2014011.
Event or Problem Description
Surgeon had trouble expanding the cage, causing a delay in surgery.

• Brand Name: ADD/SMALL VBR
• Common Device Name: ADD/SMALL VBR, 14MM, HEIGHT 16-25MM, ANGLE 0
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6763660
• Report Number: 9612420-2017-00020
• Device Sequence Number: 1967599
• Product Code: MQP
• UDI-Device Identifier: 04052536004355
• UDI-Public: 4052536004355
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K012254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: No Information
• Device Model Number: CS 2250-14-16
• Device Catalogue Number: CS 2250-14-16
• Device Lot Number: WSD14725647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2017
• Device Age: 56 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/03/2017
• 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: Hospitalization