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

Catalog Number	55840008570
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure: scoliosis levels implanted: sacrum it was reported that during surgery, the set screw could not be entered into the screw head.The product came in contact with the patient.Patient complications were reported as unknown.
Additional Manufacturer Narrative
Product analysis: the mas bone screw was returned with a set screw in the head but no rod.The threads on the head of the set screw where checked with an m9 reverse angle thread gauge and would accept the go and not accept the no/go.The saddle of the bone screw has some witness marks or the outer edges.The shaft of the bone screw was not locked into place as is typically seen when the set screw has been installed properly.The mas was functionally tested with a sample set screw and sample rod.The break-off screw functioned properly (see attached photos).The set screws returned had heavy damage to the threads and there is some damage from the threads being pulled vertically down with the screw force.There are witness marks on the face of the screws indicating that the face of the set screw contacted the rod before the node.These observations are consistent with the rod not being fully reduced before the set screw was installed into the mas.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: 6809458
• Report Number: 1030489-2017-01949
• Device Sequence Number: 19102065
• Product Code: KWP
• UDI-Device Identifier: 00643169004450
• UDI-Public: 00643169004450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: 55840008570
• Device Lot Number: H5329276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1