MAUDE Adverse Event Report: STRYKER GMBH TOETAC XPRESS MEDIUM 10 DEGREE HAMMERTOE IMPLANT; SCREW, FIXATION, BONE

Catalog Number HT-00005

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient seems to have allergic reaction to the toe tac implants.Redness and hives around the sites.Patient was revised.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for the evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 Description

It was reported that the patient seems to have allergic reaction to the toe tac implants.Redness and hives around the sites.Patient was revised.

• Brand Name: TOETAC XPRESS MEDIUM 10 DEGREE HAMMERTOE IMPLANT
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8709880
• MDR Text Key: 148402485
• Report Number: 0008031020-2019-00679
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327356298
• UDI-Public: 07613327356298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2020
• Device Catalogue Number: HT-00005
• Device Lot Number: 01240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR