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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC ACU-LOC 2 VDR PROX PLT, STD LONG, R; PLATE, FIXATION, BONE
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ACUMED LLC ACU-LOC 2 VDR PROX PLT, STD LONG, R; PLATE, FIXATION, BONE Back to Search Results
Model Number 70-0373
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00242: plate 2, 3025141-2020-00243: linkage screw.
 
Event Description
Patient experienced a fracture that was treated surgically with competitor's products.The fracture became infected and a secondary fracture formed in the old screw hole in radius.An acumed plate (long aculoc 2 vdr plate was implanted with an extension plate and the linkage screw.At 8 weeks post op, the patient came to the doctor as they felt the linkage screw fail when they lifted a small dog.
 
Manufacturer Narrative
H3: the returned acu-loc 2 vdr proximal plate, narrow, long, left was examined visually and only several scratches and discoloration were identified, likely from use/removal.Additional mdrs associated with this event: 3025141-2020-00242 follow up 1: plate 2, 3025141-2020-00243 follow up 1: link screw, 3025141-2020-00277: screw 1, 3025141-2020-00278: screw 2, 3025141-2020-00279: screw 3, 3025141-2020-00280: screw 4, 3025141-2020-00281: screw 5, 3025141-2020-00282: screw 6, 3025141-2020-00283: screw 7, 3025141-2020-00284: screw 8, 3025141-2020-00285: screw 9, 3025141-2020-00286: screw 10, 3025141-2020-00287: screw 11, and 3025141-2020-00288: screw 12.
 
Event Description
Patient experienced a fracture that was treated surgically with competitor's products.The fracture became infected and a secondary fracture formed in the old screw hole in radius.An acumed plate (long aculoc 2 vdr plate) was implanted with an extension plate and the linkage screw.At 8 weeks post op, the patient came to the doctor as they felt the linkage screw fail when they lifted a small dog.The plates and all screws were explanted.
 
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Brand Name
ACU-LOC 2 VDR PROX PLT, STD LONG, R
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
MDR Report Key10662645
MDR Text Key211873140
Report Number3025141-2020-00241
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K102998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70-0373
Device Catalogue Number70-0373
Device Lot Number322634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Date Manufacturer Received11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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