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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH STRYKER 7-HOLE ANTERIOR MIDSHAFT PLATE; PLATE, FIXATION, BONE
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STRYKER GMBH STRYKER 7-HOLE ANTERIOR MIDSHAFT PLATE; PLATE, FIXATION, BONE Back to Search Results
Model Number 628307
Device Problems Break (1069); Fracture (1260)
Patient Problems Fall (1848); Pain (1994)
Event Date 09/16/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 stryker 7-hole anterior midshaft plate, with 6 cortical screws inserted for right closed displaced midshaft clavicle fracture, on (b)(6) 2018 he fell down stairs landing on right shoulder, had pain and displacement of clavicle, xray showed acute fracture of hardware, pt returned to operating room (b)(6) 2018 for removal of broken hardware and revision orif right clavicle with stryker 7-hole superior midshaft plate.Stryker 7-hole 1/2 tubular anterior plate and total of five 3.5 cortical screws, four 3.5 locking screws and one 2.7 cortical screw.
 
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Brand Name
STRYKER 7-HOLE ANTERIOR MIDSHAFT PLATE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
selzach solothum
SZ 
MDR Report Key7957403
MDR Text Key123670554
Report NumberMW5080499
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 Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/08/2018
7 Devices were Involved in the Event: 1   2   3   4   5   6   7  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number628307
Device Catalogue Number628307
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/10/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age21 YR
Patient Weight90
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