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

Model Number	9393608
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via manufacturing representative regarding patient with unknown indication for spinal therapy suggested for transforaminal lumbar interbody fusion (tlif).Event occurred intra-op.Levels implanted l4-5.It was reported that there was a break in instrument and fragments were left in patient.Left the cage in the disc space reasonably place and would likely fuse.Implant remains in patient.No further symptoms or complications reported.Update 2020-oct-13 e1(rep); the cage broke while implanting the tip was on the inserter, the rest of the implant 90% of it was in the disc space surgeon tamped it in further and was happy with the midline final position of the implant.The crescent inserter did not break the implant broke.Crescent peek cage was a planned part of the procedure.Decompress the level and fuse the level.Pre-op diagnosis was central stenosis and a tlif to address the pathology.

• Brand Name: CRESCENT SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; DE 94469
• MDR Report Key: 10732632
• Report Number: 1030489-2020-01479
• Device Sequence Number: 3483401
• Product Code: MAX
• UDI-Device Identifier: 00613994187703
• UDI-Public: 00613994187703
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9393608
• Device Catalogue Number: 9393608
• Device Lot Number: 81JP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR