MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7576540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Type of Reportable Event	Serious Injury
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-operative diagnosis for this procedure: nerve compression 1 year after spondylodese levels implanted: l5-s1 it was reported that post-op, after one year, cannulated screw broke at s1.The patient had no complaints after 10 months, but suddenly there were some irradiation to the right leg.Patient suffered from nerve compression.After one year there was not enough fusion between l5-s1.The screw was taken out during revision surgery and the surgeon placed new screw at s1.
Additional Manufacturer Narrative
Product analysis: the mas was returned with the bone screw broken just under the head.There is significant surface damage to the portion of the bone screw that was stuck in the bone.The damaged would appear to be the result of the removal process.There are beach marks running through almost the entire fracture surface indicating cyclic fatigue.When reviewing the saddle of the mas it is noted that the rod does not appear to have been seated evenly in the saddle, which could place extra stress on the screw.The fracture does appear to be the result of cyclic fatigue followed by overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6957246
• Report Number: 1030489-2017-02220
• Device Sequence Number: 1208789
• Product Code: KWP
• UDI-Device Identifier: 00885074031132
• UDI-Public: 00885074031132
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7576540
• Device Lot Number: H5129175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention