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

Catalog Number 7078396

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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.

Event Description

It was reported that the patient underwent posterior spinal fusion due to l1 chance fracture.Intra-op, a cross-threading occurred during tightening of set screw and it was replaced with new one.There was the possibility that burr came out at the time.Reportedly, post-op x-rays showed metal fragment around 1-2mm size, so the incision site was re-opened to remove it.Each soft tissue was removed because the fragments could not be seen visually.It was confirmed by taking x-rays again that there was no problem.There was delay in the in overall procedure time by more than 60 mins.

Manufacturer Narrative

Product analysis: macroscopic and optical examination revealed thread crest/flank damage; this damage appears to have initiated near the start of the thread, and is evident around the damaged portion of the thread.Functional evaluation with a sample mas head found the set screw was unable to be fully engaged.The above observations are consistent with misalignment of the mas and set screw threads during construct assembly.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.

Manufacturer Narrative

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

• 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 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 Key: 5821613
• MDR Text Key: 50387454
• Report Number: 1030489-2016-02177
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Catalogue Number: 7078396
• Device Lot Number: H5225372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided; 08/11/2016
• Supplement Dates FDA Received: 09/07/2016; 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 76