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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. CURVED THORACIC PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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K2M, INC. CURVED THORACIC PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number SP-4199-04
Device Problems Fracture (1260); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2020
Event Type  malfunction  
Event Description
A physician reported that the depth-indicating lines on two everest specialty curved thoracic probes were incorrect and measured a greater depth than indicated.Surgery was completed with no delay using an alternate device and there was no adverse consequence to the patient.This report captures the second of two devices.
 
Event Description
A physician reported that the depth-indicating lines on two everest specialty curved thoracic probes were incorrect and measured a greater depth than indicated.Surgery was completed with no delay using an alternate device and there was no adverse consequence to the patient.This report captures the second of two devices.
 
Manufacturer Narrative
Visual inspection: the device was inspected.It was observed that the laser markings on the distal tip were not uniform in comparison to the instrument drawings.Device history records were reviewed for lot and no relevant manufacturing issues were identified during inspection.Complaint history was reviewed and no similar complaints were identified for this lot.A non-conformance was initiated to investigate the root cause associated with this failure mode.
 
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Brand Name
CURVED THORACIC PROBE
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10570106
MDR Text Key208154313
Report Number3004774118-2020-00215
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
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 Catalogue NumberSP-4199-04
Device Lot NumberMGNC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/22/2020
Supplement Dates Manufacturer Received10/31/2020
Supplement Dates FDA Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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