MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM COMPREHENSIVE POSTERIOR SYSTEM; SCREW, POLYAXIAL

Model Number	CS 3802-065-045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
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
The patient complained of persistent symptoms and underwent a revision surgery.The existing instrumentation was to be extended in order to stabilize the spine over a longer distance.When removing the already implanted rods, the surgeons determined that the screw was broken and removed it.A new larger diameter screw was implanted.

• Brand Name: UCENTUM COMPREHENSIVE POSTERIOR SYSTEM
• Common Device Name: SCREW, POLYAXIAL
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8340924
• Report Number: 9612420-2019-00002
• Device Sequence Number: 16715369
• Product Code: NKB
• UDI-Device Identifier: 04052536078837
• UDI-Public: 4052536078837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: CS 3802-065-045
• Device Catalogue Number: CS 3802-065-045
• Device Lot Number: U013772
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 10/29/2021
• 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 Weight: 78