MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	9393007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
Pre-op: multiple level degenerative disc disease procedure: transforaminal lumbar interbody fusion (tlif) levels involved: l5/s1 it was reported that during surgery, implant fractured during insertion.The implant was retrieved in two pieces.A replacement implantation was not attempted.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: macroscopic and optical inspection reveals fracture just past the ¿nose¿ of the implant, with a portion of the implant cracked and bent down into the part on one side, with gouges, and plastic deformation near the fracture location noted.Angulation and /or torsion of the implant relative to the disc space during insertion can influence the level of impaction loads, as well as the size of the implant chosen relative to the disc preparation and distraction.The type and location of breakage is consistent with overloading of the part during the attempted insertion.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRESCENT SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6321252
• Report Number: 1030489-2017-00263
• Device Sequence Number: 577692
• Product Code: MAX
• UDI-Device Identifier: 00613994187543
• UDI-Public: 00613994187543
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K094025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2017

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 Expiration Date: 09/26/2024
• Device Catalogue Number: 9393007
• Device Lot Number: H5303366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided; 03/07/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/16/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR