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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS OFFSET CONNECTOR; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE OASYS OFFSET CONNECTOR; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 48551080
Device Problems Device Operates Differently Than Expected (2913); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2015
Event Type  malfunction  
Event Description
It was reported that during surgery, it was found that the hex of connector cap was worn.So the cap was not able to loosen with driver before using.The surgeon used other smaller connector.The second connector was attached to rod in patient, but its cap was not able to be tightened.The driver did not fit the hex of the cap.After that the surgeon exchanged only the cap to a cap from other connector.
 
Manufacturer Narrative
Method: device functional inspection.Device history review.Results: device was confirmed to be fully functional.The returned connector was found to be able to place and tighten the blocker and remove the blocker without incident.Manufacturing were reviewed and no anomalies found.Conclusion: no product issue was found.
 
Event Description
It was reported that during surgery, it was found that the hex of connector cap was worn.So the cap was not able to loosen with driver before using.The surgeon used other smaller connector.The second connector was attached to rod in patient, but its cap was not able to be tightened.The driver did not fit the hex of the cap.After that the surgeon exchanged only the cap to a cap from other connector.
 
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Brand Name
OASYS OFFSET CONNECTOR
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR   33610
Manufacturer Contact
irma gamonal
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4749202
MDR Text Key17328220
Report Number0009617544-2015-00209
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K032394
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48551080
Device Lot NumberAW3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient Weight50
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