MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Nervous System Injury (2689)

Event Date 05/05/2015

Event Type  Injury  

Event Description

Rep reported "patient had medial pain at operative ankle." rep clarified that ¿surgeon thought that it is the bone that is causing the impingement due bone growth.Not the implant.¿ patient is scheduled for revision on (b)(6).

Manufacturer Narrative

The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on (b)(6) 2014.Stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting.Unknown star ankle.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device will not be returned.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4807152
• MDR Text Key: 5829591
• Report Number: 0008031020-2015-00216
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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