MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA 4.75; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number MSB_UNK_SCRW_SOLR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/04/2021

Event Type  Injury  

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 Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of upper adjacent vertebral body fracture, undergoing a revision surgery.It was reported that, at the time of the final tightening on the right side of t6, the driver's tip was broken.The broken part remained in t6 set screw and it wasn't be removed according to the physician's discretion.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product will be returned and will not be replaced.Procedure: t4/8 plf reason for revision: t8 vertebral body fracture date of initial surgery: (b)(6) type and level of initial surgery procedure:l2/3 tlif mdt products used in initial surgery: solera475, mp reoperation was performed due to t8 vertebral body fracture.Report of breakage to the final tightening driver for rmas.It was said that according to the procedure in the surgical technique, the tab was folded and final tightening was performed, but the tip broke off.There are no plans to schedule a surgery to remove the broken driver tip.Screw has been added to the event for post-op adjacent vertebral fracture.The patient had 2 more surgeries done after the initial surgery which was done in (b)(6) 2013.In the 3rd surgery, the fixation had been extended to th9-l4.Patient surgery history: initial operation: (b)(6) 2013, date was unknown.Primary disease: hernia operation details: love (l4 / 5) second operation date: unknown reason for operation performed: lcs operation details: l3 / 5 (plif) - non-medtronic products.Third operation date: unknown reason for operation performed: upper adjacent segment disease.Operation details: fixation at t9 / l4 (l2 / 3tlif)-so47, mp reason for this operation ((b)(6) 2021) performed: th8 vertebral body fracture (upper adjacent vertebral body fracture).Screw that has been added to the event had no malfunction.The set screw will not be returned for analysis as there was no malfunction.

Manufacturer Narrative

H2: additional information received stated in b5.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of upper adjacent vertebral body fracture, undergoing a revision surgery.It was reported that, at the time of the final tightening on the right side of t6, the driver's tip was broken.The broken part remained in t6 set screw and it wasn't be removed according to the physician's discretion.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product will be returned and will not be replaced.Procedure: t4/8 plf reason for revision: t8 vertebral body fracture date of initial surgery: (b)(6) type and level of initial surgery procedure:l2/3 tlif mdt products used in initial surgery: solera475, mp reoperation was performed due to t8 vertebral body fracture.Report of breakage to the final tightening driver for rmas.It was said that according to the procedure in the surgical technique, the tab was folded and final tightening was performed, but the tip broke off.There are no plans to schedule a surgery to remove the broken driver tip.Screw has been added to the event for post-op adjacent vertebral fracture.The patient had 2 more surgeries done after the initial surgery which was done in (b)(6) 2013.In the 3rd surgery, the fixation had been extended to th9-l4.Patient surgery history: initial operation: (b)(6) 2013, date was unknown.Primary disease: hernia operation details: love (l4 / 5) second operation date: unknown reason for operation performed: lcs operation details: l3 / 5 (plif) - non-medtronic products.Third operation date: unknown reason for operation performed: upper adjacent segment disease.Operation details: fixation at t9 / l4 (l2 / 3tlif)-so47, mp reason for this operation ((b)(6) 2021) performed: th8 vertebral body fracture (upper adjacent vertebral body fracture).Screw that has been added to the event had no malfunction.The set screw will not be returned for analysis as there was no malfunction.The reported screw was used in the initial surgery.There was no malfunction with the screw.It was explanted due to upper adjacent vertebral body fracture.There is a possibility that the reported screw contributed to the t8 vertebral body fracture because it is the upper end of fixation.There is still no plan to remove the driver tip with another surgery.The patient issue was resolved.

• Brand Name: CD HORIZON SOLERA 4.75
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 11662860
• MDR Text Key: 246724976
• Report Number: 1030489-2021-00482
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCRW_SOLR
• Device Catalogue Number: MSB_UNK_SCRW_SOLR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR