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

Catalog Number	75446550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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 fixation of 2 levels with 4 screws and 2 rods.Intra-op, patient's bones were very hard and on implanting the screws, tulip of one of the screws broke and was stuck in the screwdriver.The shaft of the screw was however left implanted in the bone.The surgeon added another screw in the next pedicle in order to complete the fixation.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: the mas has fractured approximately 2mm before the bone screw head.The fracture is fairly flat.Under microscopic review, there are indications of torsional overload, with little to no signs of a bending moment.There do not appear to be any defects at or near the level of fracture that could have contributed to the failure.The diameter at the level of fracture appears to meet print spec.The fracturing of the bone screw shaft appears to be the result of material overload through torsional force.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was pre operative diagnosed with isthmic spondylolisthesis grade 2 at l4-l5; and osteo condensation of vertebral bodies l4-l5-s1.

• 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: 9217509
• Report Number: 1030489-2019-01185
• Device Sequence Number: 19533499
• Product Code: KWP
• UDI-Device Identifier: 00885074134130
• UDI-Public: 00885074134130
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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 Catalogue Number: 75446550
• Device Lot Number: H5529193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 70