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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; UNID ROD
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MEDICREA INTERNATIONAL PASS LP; UNID ROD Back to Search Results
Catalog Number B33226012-08
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2019
Event Type  malfunction  
Manufacturer Narrative
Surgeon thought the rods looked small when implanting.The surgeon checked the diameter and saw 5.5mm written on the rods instead of the expected diameter of 6mm.Both rods were implanted.According to company representative surgeon did not bend the rods in surgery (even though the pre-bent rod profile is different from the planned rod profile).Rods with a diameter of 5.5mm were implanted instead of 6.0mm: the diameter has no impact on the patient.The choice of diameter is related to the surgeon's preference.The 5.5mm diameter rod is not less resistant to physiological forces no matter the size of the patient.The surgeon saw the 5.5mm marking on the rods and wanted to implant them: no risk.Different pre-bent rod profile from planned rod profile: the surgeon chose to use the rods with a different pre-bent rod profile because they allowed the surgeon to obtain a correction of the spinal deformity in terms of satisfactory lordosis (pi-ll <10 deg, pt <25 deg and sva <40mm).The patient is doing well and there are no adverse effects due to the incorrect rod diameter and rod profile.After verification, the initial planned rods (6.0mm) were exchanged with 5.5mm rods for another surgery.The 6mm rods were never sent because the surgery of the previous surgery was cancelled.The implants were transferred to the quarrantine area of medicrea international.The mix up tool place at the time of shipment.The operator performs a double check at two different times.Before the case, the distributor checked the stickers and labels and everything was labeled correctly.He did not check the rods planned for the current patient.
 
Event Description
Surgeon thought the rods looked small when implanting.The surgeon checked the diameter and saw 5.5mm written on the rods instead of the expected diameter of 6mm.Both rods were implanted.According to company representative surgeon did not bend the rods in surgery (even though the pre-bent rod profile was different from the planned rod profile).Submission of a medical device report and the fda's release of that information is not an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.
 
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Brand Name
PASS LP
Type of Device
UNID ROD
Manufacturer (Section D)
MEDICREA INTERNATIONAL
5389 route de strasbourg
rillieux-la-pape, 69140
FR  69140
Manufacturer (Section G)
MEDICREA INTERNATIONAL
5389 route de strasbourg
rillieux-la-pape, 69140
FR   69140
Manufacturer Contact
karine trogneux
5389 route de strasbourg
rillieux-la-pape, 69140
FR   69140
MDR Report Key8817682
MDR Text Key151926600
Report Number1000432246-2019-00011
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100297
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 06/27/2019,07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB33226012-08
Device Lot Number19F0382
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/24/2019
Event Location Hospital
Date Report to Manufacturer06/27/2019
Date Manufacturer Received06/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient Weight75
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