MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: ZERO-P; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number UNK - CONSTRUCTS: ZERO-P

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

Patient Problems Ossification (1428); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown constructs: zero-p/unknown lot.Part and lot numbers are unknown; udi 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.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.(b)(4).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: hu, l.Et al (2019), influence of fusion on the behavior of adjacent disc arthroplasty in contiguous 2-level hybrid surgery in vivo, world neurosurgery, vol.132, pages e929-e940, https://doi.Org/10.1016/j.Wneu.2019.07.073 (china).The objective of this retrospective study is to investigate whether the behavior of disc arthroplasty in contiguous 2-level hybrid surgery (hs) was affected by adjacent fusion in vivo compared with cervical disc arthroplasty (cda) alone.A total of 79 patients, ages ranging from 27-63 years (mean, 45 years), underwent 1-level cda or contiguous 2-level hs between january 2012 and december 2015.Of the 79 patients, 48 were assigned in the 1 level cda group (male to female ratio, 19:29) and 31 in the 2-level hs group (male to female ratio, 11:20).In hs group, anterior cervical discectomy and fusion (acdf) was performed if radiographic signs of cervical instability, advanced vertebral body spondylosis, facet degeneration, and loss of segmental mobility were noted.For acdf, a zero-p implant (synthes, (b)(4)) packed with b-tricalcium phosphate or an autograft with excised osteophyte was inserted into the prepared intervertebral space.Four locking screws were tightened to fix the zero-p implant.In the 2-level hs group, 7 segments developed radiographic adjacent segment degeneration (asd) classified as new or enlarged anterior osteophyte (6) and new or increased narrowing of disc space (1).Heterotopic ossification (ho) formation was reported in 2 patients as grade 1, in 4 patients as grade 2, in 6 patients as grade 3 and in one patient as grade 4.Other complications noted were high-grade ho in 7 patients, loss of mobility in 1 patient, subsidence >2 mm in 1 patient, and migration >3 mm in 1 patient.On 2-level hs follow-up, 11 patients showed >2° worsening of kyphosis and 2 patients showed >2 mm decrease of intervertebral disc height (idh).In conclusion, the authors reported that although fusion in 2-level hs partially affected the behavior of the adjacent disc prosthesis compared with cda alone, it did not cause severe complications and adverse clinical outcomes.Patient(s) info: zero-p implant (synthes, (b)(4)).N=7 - adjacent segment degeneration (asd) ¿ n=6 - new or enlarged anterior osteophyte.¿ n=1 - new or increased narrowing of disc space.N=13 - heterotopic ossification (ho) ¿ n=2 - grade 1, ¿ n=4 - grade 2, ¿ n=6 - grade 3, ¿ n=1 - grade 4.N=7 - high-grade ho.N=1 - loss of mobility.N=1 - subsidence >2 mm.N=1 - migration >3 mm.N=11 - >2° worsening of kyphosis.N=1 - >2 mm decrease of intervertebral disc height (idh).Treatment noted: treatment arm for the 2-level hs group.Treatment for the captured events were not provided.This report is for an unknown synthes zero-p constructs.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: ZERO-P
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9418651
• MDR Text Key: 185504882
• Report Number: 8030965-2019-70838
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: ZERO-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention