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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SCREW IMPLANT

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STRYKER GMBH UNKNOWN SCREW IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Fracture (1260)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative
This event was reported through an attorney, as a result of a legal claim. Due to the ongoing litigation no additional information is available at this time. If additional information is received it will be reported on a supplemental report.
 
Event Description
It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2016 the following procedure was performed on the right foot: derotation of the 1st ray deformity with release dense cicatrix, 1st metatarsophalangeal joint arthrodesis, resection arthroplasty 2nd metatarsophalangeal joint, and release flexor digitorum longus and plantar flexion contractures, proximate interphalangeal joint and distal interphalangeal joint with pin fixation which included the use of a plate and screws for the 1st mtp fusion. It is further alleged that on or about (b)(6) 2016 the patient returned to the surgeon with recurrence of the deformity in his right foot and it was determined that the plate and first oblique screw fractured and that there had been valgus drift. Allegedly he continues to have severe pain in his right foot and substantial issues with mobility.
 
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Brand NameUNKNOWN SCREW
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 Key7805947
MDR Text Key117895563
Report Number0008031020-2018-00572
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
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: 08/22/2018 Patient Sequence Number: 1
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