MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH DIPLOMAT

Model Number	DIPLOMAT
Medical Device Problem Codes	Misassembled (1398); Use of Device Problem (1670); Misassembly by Users (3133)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report was done as a result of fda audit: fei-no.(b)(4).
Event or Problem Description
Revision surgery because of improper application of the tulip on the screw by the surgeon within the initial surgery.The pedicle screw never was properly connected to the tulip.The flawed image of the tulip's highly inward-pointing plate clearly indicates that the head of the pedicle screw was not firmly attached to the tulip saddle.The control of the tightness of the tulip on the pedicle screw described in the surgical guide was probably not done.The same effect occurs when the tulip is placed in situ after the pedicle screw has been set.It indicates that the pedicle screw was inserted quite deeply into the pedicle, so that a complete grasping of the tulip platelets around the pedicle head was not possible during the subsequent placement of the tulip.The incorrect placement of the tulip on the screw head can thus lead already during the attachment of the rod for pushing out of the pedicle head of the tulip.The head of the pedicle screw then very probably bent the leaflets of the tulip's saddle when mobilizing the patient and later slipped out of the tulip.By overlaying the tulips and pedicle screws in the x-ray image in lateral view, this slipping out was not recognized by the surgeon.The operating instructions explicitly refer to the firm connection of tulip and pedicle screw.Once firmly connected slipping out of the head of the pedicle screw is no longer possible.The connection can transfer very heavy forces.The present error pattern is a consequence of disregarding the product information.The geometry of the rods to be inserted into the tulip must be adapted to the course of the pedicle screws / tulips.Non-observance of the surgical technique described in ifu and product information led to slipping out of a pedicle screw from the tulip.

• Brand Name: DIPLOMAT
• Common Device Name: DIPLOMAT
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, bavaria 63755 ; GM 63755
• MDR Report Key: 8563936
• Report Number: 9615021-2019-00002
• Device Sequence Number: 2091560
• Product Code: MNI
• UDI-Device Identifier: 04047844023778
• UDI-Public: 04047844023778
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: DIPLOMAT
• Device Catalogue Number: AB0030-55001
• Device Lot Number: AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/30/2019
• 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