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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER GMBH & CO. KG NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER LEIBINGER GMBH & CO. KG NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6007-103-110
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/17/2017
Event Type  malfunction  
Event Description
Upon removal of navigation pins from the tibia, the tips of both pins broke off in the bone. According to the physician's op note, the holes were pre-drilled prior to insertion. An attempt was made to remove the pins without success. The surgeon opted to leave them in as it would cause more damage to the bone to try and remove them. The sites were irrigated with antibiotic and the wound was closed. No harm has reached the patient post-op. Surgical staff notified stryker of the event and a meeting was held between surgical leadership and stryker rep. Pins of the same lot number were pulled from stock. The rep replaced the pins with a different lot number and is sending the pins from the broken lot to the stryker engineering department for further evaluation.
 
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Brand NameNA
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER LEIBINGER GMBH & CO. KG
2 pearl court
allendale NJ 07401
MDR Report Key6750032
MDR Text Key81359643
Report Number6750032
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6007-103-110
Device Catalogue Number6007-103-110
Device Lot NumberV49699
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer07/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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