MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE? UNIVERSAL ANCHORAGE 2 CP T8; PLATE, FIXATION, BONE

Catalog Number	626895
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
When the clinic was to remove an anchorage 2 plate, they discovered that implants had stained on the soft tissues of the wound.Grey discolorations in the wound were found where the plate had been sitting.The clinic had put in the plate in the first place.This university hospital is now scared to use their new variax 2 and anchorage 2 plates since this now have happened several times.Two times is reported.They need this instrument/implants but are afraid to use it.
Additional Manufacturer Narrative
The reported event that cross plate universal anchorage 2 cp t8 was alleged of 'tissue damaged' could be confirmed.The discoloration of the plate on soft tissues is a known event.A medical opinion was provided by our medical consultant: "the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to metal surface.It is the interaction of an inorganic material in titanium plates, and soft tissue and he degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials (titanium), are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action." [original statement] a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
When the clinic was to remove an anchorage 2 plate, they discovered that implants had stained on the soft tissues of the wound.Grey discolorations in the wound were found where the plate had been sitting.The clinic had put in the plate in the first place.This university hospital is now scared to use their new variax 2 and anchorage 2 plates since this now have happened several times.Two times is reported.They need this instrument/implants but are afraid to use it.

• Brand Name: CROSS PLATE? UNIVERSAL ANCHORAGE 2 CP T8
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8148237
• Report Number: 0008031020-2018-01038
• Device Sequence Number: 19204307
• Product Code: HRS
• UDI-Device Identifier: 07613327130829
• UDI-Public: 07613327130829
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K151769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: Lay User/Patient
• Device Catalogue Number: 626895
• Device Lot Number: L08437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1