MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 2968845

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 03/23/2016

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 r eported event.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.

Event Description

Pre-op diagnosis: lumbar canal stenosis (lcs), procedure: oblique lumbar interbody fusion (olif), levels: l3-5 it was reported that, intra-op, the surgeon used a sleeve remover for removing a sleeve after placing the cage.The surgeon turned round and round a handle and it came off from the cage so the inserter was detached.It was found that the cage was deviated to opposite side by x-ray.No image was used while the surgeon was using the sleeve remover.There was delay in the overall procedure time by more than 60 minutes.At the beginning of the surgery, the surgeon performed from left side but the cage deviated in opposite side so he had to approach from right side to replace the cage with 2mm bigger one.The surgeon was watching intra-operative imaging when he was operating at l3/l4 but when he was operating at l4/l5, he did not pay much attention to the imaging.When the surgeon confirmed the imaging after using a remover, the cage was half protruded from vertebral body.The cage was removed from right side and reinserted.After that, the surgeon carefully used the remover but the cage was pushed in so he adjusted the location of the cage with a slap hammer.Patient complications were reported unknown.

Manufacturer Narrative

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

• Brand Name: CLYDESDALE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5583889
• MDR Text Key: 42852262
• Report Number: 1030489-2016-01129
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2968845
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00074 YR