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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL IRELAND, LTD. OSSEOFLEX STEERABLE NEEDLE
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MERIT MEDICAL IRELAND, LTD. OSSEOFLEX STEERABLE NEEDLE Back to Search Results
Catalog Number OF-0231/B
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account stated that the needle became stuck in the patient during a kyphoplasty procedure.The patient was sent to the or to have the needle removed by a spine surgeon.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause is attributed to use error/off-label use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.
 
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Brand Name
OSSEOFLEX STEERABLE NEEDLE
Type of Device
STEERABLE NEEDLE
Manufacturer (Section D)
MERIT MEDICAL IRELAND, LTD.
parkmore industrial estate
ballybrit,
EI 
MDR Report Key8831573
MDR Text Key152350263
Report Number9616662-2019-00010
Device Sequence Number1
Product Code GEA
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberOF-0231/B
Device Lot NumberK1525007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2019
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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