MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH TOSCA; TOSCA VARIABLE ANGLE SCREW Ø4.0X12MM

Model Number	TOSCA
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Injury (2348)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Summary the complaint of the broken tosca screw and breakage while explantation is not justified.Please refer to the (b)(4) investigation report.
Event or Problem Description
Patient was initially treated with an kaden cage in c6/c7.Implantation date is unknown.Later occurence of pain in c5/c6 led to an additional treatment with nubic cage and tosca plate system with the remaining kaden cage in c6/c7.Date of this treatment is unknown.Nubic and tosca expansion screws were fused.Kaden cage was not fused.Due to an instability of the cervical column x-ray of (b)(6) 2019 image showed a breakage of a tosca screw in c7.Surgeon decided to explant kaden cage and broken tosca screw.Therefore tosca plate had to be explanted.Under explantation all fixation screws of tosca broke.Several instruments were damaged.Parts of the broken screws remained in the vertebrae.

• Brand Name: TOSCA
• Common Device Name: TOSCA VARIABLE ANGLE SCREW Ø4.0X12MM
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, 63755 ; GM 63755
• MDR Report Key: 9308320
• Report Number: 9615021-2019-00006
• Device Sequence Number: 2360725
• Product Code: KWQ
• UDI-Device Identifier: 04047844002766
• UDI-Public: 04047844002766
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: TOSCA
• Device Catalogue Number: DV-4012
• Device Lot Number: KF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOSCA - PLATE SYSTEM - EXPLANTATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR