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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 54840016540
Device Problem Break (1069)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Depression (2361); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative

Quantity of the product is unknown so only one report has been filed. : only year is valid in explant date. (b)(6). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that on an unknown date, post-op, the implanted screw broke and patient suffered with unspecified injuries and discomfort as a result. Patient underwent a revision for removal.

 
Manufacturer Narrative

Multiple products were involved in the event. Although it is unknown which of the devices caused or contributed to the reported event we are filing this report for notification purposes. Following additional screws were involved in the event: (b)(6)2013, (b)(4). (b)(6)2013, (b)(4). (b)(6)2013. (b)(4), (b)(6)2013. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that on: (b)(6)2013:patient presented with pre-op diagnosis of diskogenic pain with degenerative disk disease, lumbar pain, l4-5, l5-s1. Procedure performed: 1. Anterior lumbar interbody fusion, l4-5, l5-s1 2. Implantation of bone spacer, l4-5, l5-s1 3. Anterior plating, l4-5, l5-s1 4. Anterior diskectomy, l4-5, l5-s1 as per op notes: the anterior longitudinal ligament and annulus were incised and diskectomies performed at l4-5 and l5-s1, all the way back to the posterior longitudinal ligament. Both were sixed to a 15 mm and 15 mm spacers were selected after being packed with bone matrix. The implants were then put in place at l4-5, l5-s1 level. Then, at the l5-s1 level a 3 hole plate was attached using three 25 mm screws and was locked into position. At the l4-l5 level a 4-hole plate was attached using four screws and one 30 mm screw. Lateral fluoroscopy showed good position. Wound was closed. (b)(6)2013: patient underwent the following procedures: 1. Posterior percutaneous fusion at l4-l5, l5-s1 with facet fusion right l4-l5. L5-s1 2. Percutaneous screw placement l4,s1 3. Allograft grafting as per op notes: ¿ patient was taken to the operating room, where after an adequate level of general anesthesia, patient was placed in the probe position. Under fluoroscopic guidance, the pedicles on the left side were localized and a small skin incisions were made over the area. A 50 mm screw was placed at l4 and a 45 mm screw placed at s1. The guidewires were removed. The 70 mm rod was selected , passed through the screw heads. The device was removed and the arms was removed. Irrigation was performed. Rotation was done and measurement with tapping and a 50 mm screw placed at l4 and a 40m mm screw at the sacrum. Rod was locked into position. The arm was removed. Hemostatsis accomplished. The wound was closed using vicryl and staples on the skin. Patient was taken to the recovery room. (b)(6)2016: patient presented with low back pain, hip pain, leg pain. Xray impression: status post lumbar fusion with improvement. Thigh thrusts lateral compression, and gaenslen are positive on the right. (b)(6)2017: patient presented with back pain. Review of systems: patient is positive for low back pain, numbness in left leg and de pression. Fusion appears to be incorporated anteriorly.

 
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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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7030883
MDR Text Key92018665
Report Number1030489-2017-02330
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK091974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number54840016540
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated By Manufacturer? No
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: 11/14/2017 Patient Sequence Number: 1
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