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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. LSB ANCHOR BOLT; ANCHOR BOLTS

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AD-TECH MEDICAL INSTRUMENT CORP. LSB ANCHOR BOLT; ANCHOR BOLTS Back to Search Results
Catalog Number SEE H.10 FOR INFORMATION
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/11/2020
Event Type  malfunction  
Manufacturer Narrative
Impacted devices: lsbk1-ax-05, lot 732733734, expiration 01/01/2022, udi (b)(4).Lsbk1-bx-05, lot 735736737, expiration 03/01/2022, udi (b)(4).The preliminary risk assessment was conducted for this issue on 10-8-2020.According to the assessment anchor bolts were placed without issue.Eeg signals were monitored and the patient experienced only non-violent seizures.Anchor bolts were found broken when removing the dressing from the patient's head after monitoring without a known cause.Additional actions were taken to remove the anchor bolts from the skull, so mechanical energy.Damage to healthy tissue, severity 4, is the most applicable potential harm.The patient was reported as okay following the removal.
 
Event Description
During removal of the patient's head dressing it was discovered that the anchor bolts had broken off at the skull.The retained threads were surgically removed without further harm to the patient.
 
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Brand Name
LSB ANCHOR BOLT
Type of Device
ANCHOR BOLTS
Manufacturer (Section D)
AD-TECH MEDICAL INSTRUMENT CORP.
400 west oakview parkway
oak creek WI 53154
Manufacturer (Section G)
AD-TECH MEDICAL INSTRUMENT CORP.
400 west oakview parkway
oak creek WI 53154
Manufacturer Contact
pamela stogsdill
400 west oakview parkway
oak creek, WI 53154
2626341555
MDR Report Key10652150
MDR Text Key238830639
Report Number2183456-2020-00025
Device Sequence Number1
Product Code GZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Physician
Type of Report Initial
Report Date 10/08/2020
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 NumberSEE H.10 FOR INFORMATION
Device Lot NumberSEE H.10 FOR INFORMATION
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received10/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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