MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number G9010001607

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Patient Problem/Medical Problem (2688); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this part is not approved for use in the united states; however a like device catalog # 8292035, udi# (b)(4), 510k #k031967 was cleared in the united states.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

Pre op diagnosis: false joint occurred post op, connector come off at multiple places after final tightening.The patient had difficulty in both standing and sitting for a long time.

Event Description

Patient demographics: gender- male, age- 60 years pre op diagnosis: false joint occurred implant date: (b)(6) 2019 explant date: (b)(6) 2020 (planned) initial surgery details: procedure performed: posterior lumbar interbody fusion (plif) at l5/s in 2011 and posterior lumbar interbody fusion (plif) at l3/4 in 2019 and posterior lumbar fusion (plf) was performed at l4/5 on (b)(6) 2019 it was reported that post op, products backed out and malpositioned.The connector backed out after final tightening.Final tightening of the set screw came off and false joint occurred.The patient had difficulty in both standing and sitting for a long time.The connector of tsrh rp2 had come off at multiple places, but the cause was not mentioned.In the report, four connectors were reported, but it was unclear if they all had come off.A re-operation was performed on (b)(6) 2020.

Manufacturer Narrative

H3: product analysis: g9010001607 lot# 0519818w visual and optical examination identified that the t-bolt appears to be damaged in several locations from what appears to be overload.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.

• Brand Name: TSRH SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10357058
• MDR Text Key: 201436081
• Report Number: 1030489-2020-01023
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 02/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: G9010001607
• Device Catalogue Number: G9010001607
• Device Lot Number: 0519818W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Manufacturer Received: 07/05/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR