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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 2.3MM X 22MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE
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ACUMED LLC 2.3MM X 22MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE Back to Search Results
Model Number CO-T2322
Device Problem Device Damaged by Another Device (2915)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
Additional mdrs associated with this event: 3025141-2020-00289: driver, 3025141-2020-00290: plate 1, 3025141-2020-00291: plate 2, 3025141-2020-00292: screw 1, 3025141-2020-00293: screw 2, 3025141-2020-00295: screw 4, and 3025141-2020-00296: screw 5.
 
Event Description
While implanting a screw into an aculoc plate in the patient, the driver tip broke off in the screw head and was left implanted.
 
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Brand Name
2.3MM X 22MM LOCKING CORTICAL SCREW
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
micki anderson
5885 ne cornelius pass road
hillsboro, OR 97124
MDR Report Key10940840
MDR Text Key220963407
Report Number3025141-2020-00294
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K120903
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCO-T2322
Device Catalogue NumberCO-T2322
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2020
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 Number1
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