MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL SPACER-CR LORDOTIC 5MM HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 889.921S

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

Patient Problem Fistula (1862)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown cage spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 a cervios cage and cervical spine locking plate (cslp) were explanted one (1) month post implantation due to a one (1) cm liquor fistula at the area of the larynx.The liquor fistula was a result of non compliance and excessive vomiting of the patient which resulted in the revision, not due to implant failure.Concomitant devices reported: unk - cage/spacers: cervios (part unknown, lot unknown, quantity 1).Unk - plates: spine-us (part unknown, lot unknown, quantity 1).This is report 1 of 8 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.B3: event year is reported as 2020; however exact date of event is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional event information there were six screws have been explanted.Part and lot numbers unavailable.Parts will be returned under (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional device product code: odp d4: expiration date d9; e1 h3, h6: a product investigation was conducted.Visual inspection: the cervios curved siz 6 peek (p/n: 889.921s, lot number: 9044622) was received at us cq.Visual inspection of the complaint device showed no damage or defects with the complaint device.Investigation conclusion: this complaint is not confirmed as no issues were identified on the complaint device that would contribute to the adverse event.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 889.921s lot: 9044622 manufacturing site:bettlach.Release to warehouse date: 28 july 2014.Expiry date: 01 july 2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D1; d2a; d2b; d4; g1; g4.

Event Description

This report is for one (1) vertebral spacer-cr lordotic 5mm height.

• Brand Name: VERTEBRAL SPACER-CR LORDOTIC 5MM HEIGHT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11019563
• MDR Text Key: 222022533
• Report Number: 8030965-2020-09776
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• PMA/PMN Number: K120275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

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 Catalogue Number: 889.921S
• Device Lot Number: 9044622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 03/11/2021
• Supplement Dates FDA Received: 01/18/2021; 04/05/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention