MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	7713513
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2017
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
It was reported that on (b)(6) 2017, patient presented with pre-op diagnosis as: cervical stenosis.For which patient underwent anterior cervical discectomy with fusion (acdf) procedure.Intra-op, screw was broken.The product came in contact with the patient.No fragment of the implant remained in the patient.No patient complications were reported for this event.
Additional Manufacturer Narrative
Additional information: product analysis: microscopic examination appears to show fairly ductile fracture.Microscopic examination appears to show helical fracture with circular material flow with shaft angulation, suggesting torsional overload the above observations are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6699665
• Report Number: 1030489-2017-01711
• Device Sequence Number: 1291620
• Product Code: KWQ
• UDI-Device Identifier: 00643169329256
• UDI-Public: 00643169329256
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141632
• 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
• Report Date (Section B): 09/21/2017

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 Catalogue Number: 7713513
• Device Lot Number: H5363638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR