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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 55840008570
Device Problem Break (1069)
Patient Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
 
Event Description
Pre-op diagnosis: degenerative spinal disease and previous t11-pelvis fusion ((b)(6) 2015) procedure: revision pelvis screws to previous t11-pelvis fusion levels implanted: t11-pelvis it was reported that post-op, distal component of broken screws were too deep in pelvis to be removed. Movement was visible during surgery at s1/pelvis junction. The patient suffered from pain and hence a revision for the pelvic screws was done. Fragments of the product remained in the patient as distal component of broken screws could not be removed because they were too deep in pelvis to be removed without additional trauma to patient.
 
Manufacturer Narrative
Image review: post-op images from t11 to iliac surgery shows fracture of the iliac and sacral screws bilaterally. There is a small l5-s1 interbody device with a paucity of bone graft at this level. The fracture of the iliac screw appears to be deep and difficult to remove, contributing factors include failure of fusion. Hardware placement and alignment appear satisfactory. Root cause: patient factors.
 
Manufacturer Narrative
Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture at approximately ~8-9 threads from the base of the bone screw head. Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation. Microscopic examination of the fracture surface identified gently curving convex striations through the cross sectional area of the implant, which are indicative of cyclic fatigue until subsequent mechanical failure of the implant. Dimensional inspection of major and minor diameter confirms conformance to print specification. After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant components. The above observations are consistent with cyclic fatigue.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6165677
MDR Text Key62079541
Report Number1030489-2016-03391
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number55840008570
Device Lot NumberH5176195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2015
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: 12/12/2016 Patient Sequence Number: 1
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