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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ANCHORAGE PLATING SYSTEM IMPLANT

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STRYKER GMBH UNKNOWN ANCHORAGE PLATING SYSTEM IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
Patient Problems Wound Dehiscence (1154); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device not available.
 
Event Description
This pi is for the revision of primary implants. In the journal of the american podiatric medical association september 2016 volume 106, a poster abstract reports the following: "cast study: a (b)(6)-year-old female presented with a painful pes planovalgus deformity. Using titanium alloy hardware consisting of the stryker anchorage plating system and 7. 0mm stryker headless compression screws. A medial displacement calcaneal osteotomy and a first metatarsal-cuneiform arthrodesis was performed. [three weeks post operatively] there was still erythema [reddening of the skin] present not typical with this post-operative course. By the fourth post-operative week, the first metatarsal-cuneiform arthrodesis incision had dehisced with hardware exposed and the patient began to develop hives on her back. She was admitted to the hospital for aggressive wound management and surgical exploration. The patient underwent a second procedure for surgical debridement and delayed primary closure. Ten days after the debridement and closure revealed a larger erythematous reaction at both surgical sites. She was referred to an allergist. Positive results were detected for titanium and vanadium allergy. Throughout the course, she underwent multiple procedures for debridement and removal of all internal fixation. ".
 
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Brand NameUNKNOWN ANCHORAGE PLATING SYSTEM
Type of DeviceIMPLANT
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 Key7925631
MDR Text Key122327731
Report Number0008031020-2018-00709
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
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 Treatment Data
Date Received: 10/02/2018 Patient Sequence Number: 1
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