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

Catalog Number	9393010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent lumbar decompression and internal fixation due to spinal stenosis.Intra-op, spacer was broken.No any fragment of the implant were remaining in the patient body.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis results: visual and optical examination confirmed the cannulated drill tip has been sheared off between the drill tip and the driving shaft.It appears the tip of drill broke due to bend stress overload.The drill bit appears to be heat treated properly.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: 9373780
• Report Number: 1030489-2019-01337
• Device Sequence Number: 3040341
• Product Code: MAX
• UDI-Device Identifier: 00613994187628
• UDI-Public: 00613994187628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 02/04/2023
• Device Catalogue Number: 9393010
• Device Lot Number: H5165691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR