MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX DR PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains implanted.

Event Description

The surgeon at the hospital, reported to the sales rep, that "a patient was implanted with a variax dr plate and developed an allergy around the operated area." surgeon requested information on the chemical composition of the plate and screws.

Manufacturer Narrative

The reported event that unknown_(b)(4)_product (as reported: unknown variax dr plate) was alleged of issue s-80 (allergic reaction) could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.For the same reasons, the actual raw material certificate could not be reviewed.Nevertheless, the variax dr plate is made from titanium.All variax implants are made from titanium or titanium alloy.Up to now, there is no evidence that implants made from titanium have any potential for allergic reactions in general.In particular, these plates have no nickel content.Therefore, an allergic reaction caused by nickel is excluded.Allergic reaction caused by nickel (and chromium) is a significant problem of implants made from stainless steel alloys, but not for implants made from medical grade titanium (alloy).Note that no causal relationship between our implants and the actual infection can be associated.As per ifu (v15013) '' stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.Stryker implants include varying designs of internal fixation devices and auxiliaries manufactured from materials recognized and accepted for implantation into the body.These materials conform to astm and/or iso standards.[¿] important information for doctors and or staff: ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.[¿] contraindications: the physician¿s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment.Conditions presenting an increased risk of failure include: ¿ any active or suspected latent infection or marked local inflammation in or about the affected area.¿ material sensitivity, documented or suspected.Adverse effects: in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: [¿]¿ early or late infection, both deep or superficial.[¿]¿ material sensitivity reactions in patients following surgical implantation have rarely been reported, however their significance awaits further clinical evaluation.¿ [original statements] please keep in mind that the instructions for proper use of the devices should be followed at all times.Patients should always be tested for allergies, prior to the implantation, since allergic reactions are possible adverse events.A potential allergy of the patient to the implanted material, could have definitely led to the reported reaction.Please note that more detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The surgeon at the hospital, reported to the sales rep, that "a patient was implanted with a variax dr plate and developed an allergy around the operated area." surgeon requested information on the chemical composition of the plate and screws.

• Brand Name: UNKNOWN VARIAX DR PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7315294
• MDR Text Key: 101564489
• Report Number: 0008031020-2018-00157
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other