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

Model Number MSB_UNK_SET SCREW

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from healthcare provider via manufacturing representative regarding patient with c6 fracture diffuse idiopathic skeletal hyperostosis (dish) suggested for spinal therapy.Event occurred intra-op.Procedure used was cervical posterior fusion, levels implanted c3/th2.It was reported that at set screw final tightening, screw stripped.There was delay of less than 60 mins.It was the operation with 12 units of screws, 2 units of crosslink being placed.Of these, about 8 set screws for screws and 4 set screws on both sides of the crosslink, stripping occurred at final tightening.It stripped from the first one, but there was only one driver, all were used with the same driver.Therefore, the final tightening was performed manually and completed.In addition, on the next day, the rod was replaced.The reason was that, originally there was paralysis on right body due to trauma, and paralysis spread to left body.Opll may have become a compression factor due to the correction, so the rod was replaced to re-bend.The progress is unknown.When the set screw that stripped at final tightening was removed, it was able to be removed without stripping.No patient symptoms or further complications reported.Device will be returned.Update ; unknown whether the screwdriver itself stripped or not.No patient symptoms.Update ; in the reoperation on (b)(6) 2020, the rod placed on (b)(6) 2020 was bent again and placed again.About the reason for paralysis, do not change the information "opll may have become a compression factor due to the correction." reported in the first report.The current patient status is unknown.Update; after re-evaluating the reported event(no new information),it was found some plis need to be changed.As 2 crosslinks¿ setscrews(2 setscrews for each) were complained, changed pli110&120 to crosslinks.Void pli130 and 140.Update; the setscrews were removed once in the revision surgery because the surgeon needed to re-bend rods.We do not have the information whether the setscrews were implanted again or new setscrews were used in the revision surgery.¿it was able to be removed without stripping¿: this suggests these setscrews might not be stripped because they were able to be removed without any problems.However, since we could not tell if the setscrews were really stripped or not because we had not obtained them, we consider the setscrews were stripped.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10940335
• MDR Text Key: 219373907
• Report Number: 1030489-2020-01742
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SET SCREW
• Device Catalogue Number: MSB_UNK_SET SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• 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