MAUDE Adverse Event Report: SYNTHES GMBH UNK - VEPTR IMPLANTS: SUPERIOR CRADLE; PROSTHESIS, RIB REPLACEMENT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.This report is for an unk - veptr implants: superior cradle/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: (b)(6).Postal code (b)(4).Without a lot number, the device history records review could not be completed as no product was received.Based on the information available, it has been determined that no corrective and 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 canada as follows: this report is being filed after the review of the following journal article: peiro-garcia a., et al (2021) early complications in vertical expandable prosthetic titanium rib and magnetically controlled growing rods to manage early onset scoliosis, int j spine surg , volume 15 (2), pages 368-375 (canada).This retrospective, single-center cohort study aims to examine whether surgical treatment of early-onset scoliosis (eos) with magnetically controlled growing rods (mcgr) or vertical expandable prosthetic titanium rib (veptr) resulted in fewer short-term (24 months) complications and reoperations.Between 2010 and 2016, the medical records of 35 consecutive patients who underwent spine instrumentation with either veptr or mcgs for the management of eos were reviewed.Of the 35 patients included for analysis, 2 cohorts were defined: 20 patients were included in the veptr (depuy synthes, raynham, massachusetts) cohort and 15 patients were included in the mcgr (magec system, nuvasive, san diego,california) cohort.The median age of patients in the mcgr cohort was older than that of patients in the veptr cohort.Following the publication of the nice study in 2014, the pediatric spine surgeons at our academic center began using mcgrs to manage eos.Therefore, all veptr patients reported in this study had their index surgery prior to this change in practice.Patients completed a minimum of 2 years clinical follow-up.Reported complications: total complications (n=16) and no.Of patients (n=13) 2 infection, one patient required 4 surgical debridements, whereas the other was successfully managed with 1 surgical debridement.Five patients required a new rod insertion in less than a year due to curve progression or needed a new rod because the previous one was fully expanded.One patient with a unilateral rod required a new contralateral veptr insertion in less than a year due to curve progression.3 pneumothorax (1x) three patients had intraoperative pneumothorax during veptr insertion requiring intraoperative chest tube insertion; 1 pneumothorax (2x) 1 patient had a pneumothorax during the veptr rod insertion and a subsequent pneumothorax during a separate lengthening, requiring (like the other 3 patients) a chest tube.1 neurological injury, one veptr patient had a permanent neurologic injury in the immediate postoperative period due to spinal cord ischemia despite the lack of monitoring changes during surgery.The patient who suffered a neurologic injury had her rods removed on postoperative day 1 and would subsequently have new veptr rods inserted 1 month later without any further complications.Sixteen unplanned surgeries were performed on 10 patients in the veptr cohort.The percentage of main curve angle correction with surgery was significantly higher in the mcgr group (veptr, 208 [_15.2, 58]; mcgr, 47.28 [13, 59.7]; p ¼.0138).The avt correction was significantly higher in the mcgr group, with a median of 18 mm (1, 50), whereas the median correction in the veptr group was 6 mm (_8, 64; p ¼.0263).-postoperative t1-t12 and t1-s1 heights were significantly higher in the mcgr cohort, with a median t1-t12 of 207 mm (136, 295) and median t1-s1 of 336 mm (228, 471), compared with a median t1-t12 height of 167 mm (95, 228; p ¼.0174) and median t1-s1 height of 273 mm (183, 371; p ¼.00647) in the veptr group.7 implant failure requiring surgery within 1 year of index surgery.5 patients had proximal anchor dislodgement or migration.1 patient had a pelvic cradle migration to the pelvis.1 patient had a pelvic cradle breakage.This report is for unknown synthes veptr.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: SUPERIOR CRADLE
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15350182
• MDR Text Key: 299189931
• Report Number: 8030965-2022-06358
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• 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