MAUDE Adverse Event Report: ULRICH GMBH & CO. KG MAMBO; BONESCREW, SELF DRILLING, GREY, 3.5MM, LENGTH 13MM

Model Number	CS 1830-13
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2016
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 we recognize that this mdr is being submitted after the 30 day deadline.During a review of complaints, we realized there had been an oversight and this needed to be filed, so we are submitting it now.H3 other text : device not returned.
Event or Problem Description
An x-ray one month post-operatively revealed that one of the four bone screws was backing out.As of now we do not know whether a revision surgery has been scheduled or not.

• Brand Name: MAMBO
• Common Device Name: BONESCREW, SELF DRILLING, GREY, 3.5MM, LENGTH 13MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6358418
• Report Number: 9612420-2017-00001
• Device Sequence Number: 10954583
• Product Code: KWQ
• UDI-Device Identifier: 04052536008322
• UDI-Public: 4052536008322
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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 1830-13
• Device Catalogue Number: CS 1830-13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 02/24/2017
• 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