MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS, RIB REPLACEMENT

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Report is for an unknown - veptr implants: veptr ii/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.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary, the investigation could not be completed; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: hell ak.Et al (2018), combining bilateral magnetically controlled implants inserted parallel to the spine with rib to pelvis fixation surgical technique and early results, clinical spine surgery, volume 31, number 6, pages 239-246, (germany).This paper describes a novel technique using the traditional bilateral veptr coastal and pelvic fixation described by campbell et al to stabilize the spine in children with neuromuscular scoliosis in combination with externally controlled magnetic device and reports the early clinical results and complications of this technique.A total of 18 children with neuromuscular or syndromic scoliosis who have been treated by a new surgical technique with a competitor¿s externally controlled magnetic rod system in combination with a bilateral rib to pelvis fixation using the hardware parts of the unknown synthes vertical expandable prosthetic titanium rib (veptr) ii system were included in the study.There were 8 female and 10 male patients, with a mean age of 8.6 years at the time of primary implantation of the magnetic-controlled rods.Of these patients, 7 children had a bilateral ¿classical¿ veptr implant before the magnetic controlled rod implantation.Their average age at the primary veptr implantation was 7.1 years.These children had an average of 5 surgical lengthening procedures (range, 2¿9) and an average follow-up of 3 years before the magnetically controlled rod index surgery.11 patients received the magnetic rod implantation as the primary treatment.Their average age was 7.7 years at the initial surgery.All children underwent outpatient lengthening of the implants without anesthesia or analgetics.The first lengthening procedure was done in an outpatient setting 5 months after the initial surgery and every 3 months thereafter.Each implant was distracted by 0.5 cm routinely.All children received radiographs in 2 planes before and after the procedure.The average follow-up of all children after magnetically controlled implant surgery was 1.2 years.Complications were reported as follows: 1 child had an implant disconnection due to different implant diameters (5.5 mm vs.6 mm).1 child with an increased bmi had a rib fracture and implant dislocation requiring surgical revision.This report is for one (1) device- unknown synthes vertical expandable prosthetic titanium rib (veptr).This impacted product captures the following adverse event: implant disconnection due to different implant diameters this is report 1 of 1 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.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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8746414
• MDR Text Key: 149621469
• Report Number: 8030965-2019-65884
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 06/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention