MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: SYNEX; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number UNK - VERT BODY REPLACE - EXP:

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - cage/spacers: syncage/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: hrabálek l., bucil j., vaverka m., houdek m., (2010) thoracolumbar disc injury - indication for anterior disc replacement using magnetic resonance imaging,ceska a slovenska neurologie a neurochirurgie , volume 73/106(3), pages 238-244 (czech republic).This prospective randomized comparative study aims to find statistically significant different results and thus demonstrate whether the findings obtained in magnetic resonance imaging can be used to indicate anterior disc replacement.From june 30, 2004 to december 31, 2007.A total of 83 patients (55 males and 28 females) aged 16-77 years (mean age 48.36 years) with injury of one vertebra of the thoracolumbar junction (th11-l2) and without damage to nerve structures (frankel e) were included in the study.The patients were divided into three subgroups according to treatment modality.Group 1: group included 42 patients 1 operated on by a posterior tranpendicular fixation (tp fixation) using a competitors device with transpedicular replacement of vertebral body bone tissue - spongioplasty using bioactive material (chronos, synthes, usa).Group 2: contained 28 patients treated with combined stabilization tp fixation and in the second period by anterior replacement disc replacement using a titanium spacer by syncage (synthes, usa) or a harms mesh (johnson and ,johnson, usa) and anterior vertebral body replacement using a a titanium expandable synex (synthes, usa) or a harms mesh filled with autologous bone was used.Group 3: had 13 patients solved by anterior replacements or vertebral body only with anterior splint fixation using a competitors device or tslp (synthes, usa).The follow-up period was 18 months.The following complications were reported as follows: after 18 months, evaluation was done of vas (visual analogue scale) at rest and after a natural workload of the patient, the degree of pain (pain scale, scheme 2).-a case of a (b)(6) year oldmale had a pain score of 3.-a case of a (b)(6) year old female had a pain score of 3.-a case of a (b)(6) year old male had a workload vas score of 6.-a case of a (b)(6) year old female had a workload vas score of 7.-a case of a (b)(6) year old female had a workload vas score of 6.-a case of a (b)(6) year old male had had a pain score of 3.-a case of a (b)(6) year old female had a pain score of 4.-a case of a (b)(6) year old male had a pain score of 4 and workload vas score of 8.-a case of a (b)(6) year old male had a pain score of 4 and workload vas score of 8.-a case of a (b)(6) year old male had a pain score of 3.-a case of a (b)(6) year old female had a pain score of 3 and workload vas score of 7.-a case of a (b)(6) year old male had a pain score of 3 amd workload vas score of 8.-a case of a (b)(6) year old male had a pain score of 4 and workload vas score of 8.-a case of a (b)(6) year old male had a pain score of 4 and workload vas score of 8.-a case of a (b)(6) year old male had a pain score of 4 -a case of a (b)(6) year old male had a pain score of 4 and a workload score of 7.-a case of a (b)(6) year old female had a pain score of 4 and a workload score of 7.-a case of a (b)(6) year old male had a pain score of 4.-a case of a (b)(6) year old male had a pain score of 4 and workload vas score of 8.-a case of a (b)(6) year old male had a pain score of 3.(group 2).-a case of a (b)(6) year old female had a pain score of 3.(group 2).-a case of a (b)(6) year old male had a pain score of 3.(group 2).-a case of a (b)(6) year old male had a pain score of 4.(group 2).-a case of a (b)(6) year old femlae had a pain score of 4 (group 2).-a case of a (b)(6) year old had male had a pain score of 3 and workload vas score of 8.(group 3).-a case of a (b)(6) year old female had a pain score of 3.(group 3).-a case of a (b)(6) year old male had a pain score of 3.(group 3).-another patient after combined surgery, a slight ventral ejection of the implant has shown early after replacement of the disc, without the dislocation progressing any further and with healing by fusion.-transpedicular screws broke in two patients, two of whom had undergone isolated posterior fixation (7 and 15 months after surgery).-transpedicular screws broke in one patient and had undergone combined stabilization (two years after surgery).This report is for an unknown synthes bioactive material chronos, titanium spacer syncage, anterior vertebral body replacement a titanium expandable synex , tslp.This report is 10 of 10 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.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

5/1/2020: updated note for split pc¿s due to more than 10 impacted products: the complaint involves 46 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 5 separate complaints as listed below: for the overall complaint, adverse event review activity, mdv activity, and additional information request activity will be documented in (b)(4).(1st pc) (b)(4) this complaint will include 10 devices ¿ 10 synthes bioactive material chronos (1st pc) (b)(4) this complaint will include 9 devices -9 synthes bioactive material chronos(2nd pc) (b)(4) this complaint will include 10 devices ¿ 5 unk - cage/spacers: syncage ; 4 unk - vertebral body replacement - expandable: synex (3rd pc) (b)(4) this complaint will include 8 devices ¿ 2 unk - cage/spacers: syncage, 2 unk - vertebral body replacement - expandable: synex; 2 (b)(4) : unk - plates: thoracolumbar spine locking plate (tslp) and 2 (b)(4) : unk - screws: locking (4th pc).(b)(4) this complaint will include 9 devices ¿2 cage/spacers: syncage; 2 unk - vertebral body replacement - expandable: synex; 1 unk - plates: thoracolumbar spine locking plate (tslp); 1 (b)(4) : unk - locking/set screws; 3 (b)(4) : unk - mono/polyaxial screws: uss (5th pc).

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: SYNEX
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9996378
• MDR Text Key: 194123039
• Report Number: 8030965-2020-03096
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - VERT BODY REPLACE - EXP:
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR