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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE INC OSSEOSCREW SPINAL FIXATION SYSTEM ORTHOSIS, SPINE PEDICLE FIXATION

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ALPHATEC SPINE INC OSSEOSCREW SPINAL FIXATION SYSTEM ORTHOSIS, SPINE PEDICLE FIXATION Back to Search Results
Model Number 53065-40
Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/28/2021
Event Type  Malfunction  
Manufacturer Narrative

No evaluation possible at this time. The implant was not removed from the patient. The indications for use as stated in ins-101; the osseoscrew system (for use with the zodiac spinal fixation system and illico mis posterior fixation system) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Warnings 5. Once the osseoscrew implant has been deployed, it may be difficult to un-deploy, re-position, or remove; therefore, it is important to confirm proper placement of the osseoscrew prior to deploying the expansion feature by use of fluoroscopy or other suitable imaging technique.

 
Event Description

On (b)(6) 2021 revision surgery was conducted removing a previously implanted construct in order to perform an osteotomy. During the screw removal, the distal expansion section of the osseoscrew fracture and broke. The detached section remaining entrapped within the patients right l5. The osseoscrew spinal fixation system was originally implanted (b)(6) 2020.

 
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Brand NameOSSEOSCREW SPINAL FIXATION SYSTEM
Type of DeviceORTHOSIS, SPINE PEDICLE FIXATION
Manufacturer (Section D)
ALPHATEC SPINE INC
5818 el camino real
carlsbad CA 92008
Manufacturer Contact
richard younger
5818 el camino real
carlsbad, CA 92008
7604949286
MDR Report Key11372314
MDR Text Key242243111
Report Number2027467-2021-00004
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK181980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number53065-40
Device Catalogue Number53065-40
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2021 Patient Sequence Number: 1
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