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

Catalog Number 45440005540

Device Problem Break (1069)

Patient Problems Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review results: post-op x-rays for l4-s1 posterolateral instrumentation shows bilateral s1 screw fractures.No interbody grafts are present.There is a paucity of bone in the lateral space indicating fusion has probably not occurred.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that: on (b)(6) 2018: the patient was admitted with prolapsed intervertebral disc at l4-l5 and l5-s1, listhesis at l5-s1 with lumbar canal stenosis.On (b)(6) 2018: the patient underwent spinal decompression with pedicle screw fixation; and posterior lumbar internal fusion with bone grafting.The patient developed hypotension, malena and severe pain in abdomen.On evaluation, she was found to have erosive gastritis and an antral ulcer on gastroscopy.2 units of compatible whole blood was transfused during the stay.She was given antibiotics, ppi, haemostatics, iron supplement and other supportive measures.The patient improved and was stable at the time of discharge.On (b)(6) 2018: the patient was discharged.The patient was doing well for more than a year and then suddenly developed acute radiculopathy.She also experienced pain.She underwent x-rays, which showed 3 screws (out of the 6 implanted screws) broken.According to the surgeon, the patient needed a revision surgery immediately.

Manufacturer Narrative

Product analysis: the screw was returned having broken from approximately 5-7 threads from the head of the bone screw.A microscopic review of screw fracture faces indicates similar failure modes.The screw has progressive convex striations and beach marks through the cross-sectional area of the bone screw, until subsequent mechanical failure.It has a shear lip at final failure that is parallel with the crack origin.The root cause of the failures appears to be cyclic fatigue through wear.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The alleged screw was removed; and was prepared for return.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9133173
• MDR Text Key: 162535805
• Report Number: 1030489-2019-01089
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K142591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 45440005540
• Device Lot Number: H5242082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR