MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE LAPIDUS, RIGHT ANCHORAGE 2 CP T10; PLATE, FIXATION, BONE

Catalog Number 626894

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Discoloration (2074)

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

When the clinic was to remove an anchorage 2 plate as they had set, they discovered that implants had stained on the soft tissues of the wound.Grey discoloration where the plate had been sitting.

Event Description

When the clinic was to remove an anchorage 2 plate as they had set, they discovered that implants had stained on the soft tissues of the wound.Grey discoloration where the plate had been sitting.

Manufacturer Narrative

Please note corrections to the modified awareness date.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.Device not received.

• Brand Name: CROSS PLATE LAPIDUS, RIGHT ANCHORAGE 2 CP T10
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7911789
• MDR Text Key: 122046681
• Report Number: 0008031020-2018-00640
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327130645
• UDI-Public: 07613327130645
• Combination Product (y/n): N
• PMA/PMN Number: K151769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 626894
• Device Lot Number: V48482
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other