MAUDE Adverse Event Report: ULRICH GMBH & CO. KG MAMBO; MAMBO BONE SCREW, SELF DRILLING, GREY, 3.5MM

Model Number	CS 1830-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
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
Initial surgery was for severe myelopathy with cord spinal change at c4/5 and c5/6.Post operative x-rays revealed screw breakage occurred in (b)(6) 2013, but because of the patient's lack of pain and her general medical condition, she and the surgeon decided not to revise unless neck pain developed.She was in a car accident in (b)(6) 2014 and developed neck pain afterwards, but was not offered surgery at the time based on her medical condition.Patient presented in (b)(6) 2016 with a new stenosis at c3/4 and in (b)(6) 2016 received surgery to address this.During this surgery, the surgeon identified that all of the mambo screws including the broken one were solidly fused, so they were left in place.To address the new stenosis at c3/4, the surgeon implanted a posterior screw/rod system with laminectomy.He last saw the patient on (b)(6) 2017 and she reported that neck pain was resolved and myelopathic symptoms were improving.

• Brand Name: MAMBO
• Common Device Name: MAMBO BONE SCREW, SELF DRILLING, GREY, 3.5MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6471617
• Report Number: 9612420-2017-00012
• Device Sequence Number: 13545859
• Product Code: KWQ
• UDI-Device Identifier: 04052536008346
• UDI-Public: 4052536008346
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/06/2017

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 1830-15
• Device Catalogue Number: CS 1830-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/07/2017
• 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
• Patient Age: 67 YR