MAUDE Adverse Event Report: STRYKER GMBH L-PLATE, LEFT; PLATE, FIXATION, BONE

Model Number 40-15091

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Reaction (2414)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

Open reduction and internal fixation of the left midfoot.Metallosis was observed during removal.

Manufacturer Narrative

Correction: refer to h3 device discarded.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.In the case of metallosis, the opinion of a medical expert was requested.They stated the following; "[.] 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 the degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials (titanium), [which] 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 since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.[.]" metallosis cases can therefore be classified as patient related.They can be explained by the patient's reaction to the device.A review of the device history was not possible because the lot number was not communicated.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.H3 other text : device discarded.

Event Description

Open reduction and internal fixation of the left midfoot.Metalosis was observed during removal.

• Brand Name: L-PLATE, LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9549334
• MDR Text Key: 185558241
• Report Number: 0008031020-2020-00087
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154627998
• UDI-Public: 07613154627998
• Combination Product (y/n): N
• PMA/PMN Number: K063875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 40-15091
• Device Catalogue Number: 40-15091
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR