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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE
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X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Model Number T066-0205
Medical Device Problem Codes Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant reported to the company that a guided angled awl tip broke inside a cage during surgery.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released for distribution.The damage to the distal tip of the awl could be replicated if lateral force was applied while seated in an implant, or from failure to use the guided inserter.
 
Event or Problem Description
The complainant reported to the company that a guided angled awl tip broke inside a cage during surgery.There were no known patient complications.
 
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Brand Name
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
Common Device Name
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
X-SPINE SYSTEMS, INC.
664 cruiser lane
belgrade MT 59714
MDR Report Key7681901
Report Number3005031160-2018-00021
Device Sequence Number634410
Product Code HWJ
UDI-Device IdentifierM697T06602051
UDI-PublicM697T06602051
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K162944
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/12/2018
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
Operator of Device Health Professional
Device Model NumberT066-0205
Device Lot NumberEM14F003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/14/2018
Initial Report FDA Received Date07/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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