MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: veptr/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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

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: xu, l et al (2020), is growth-friendly surgical treatment superior to one-stage posterior spinal fusion in 9- to 11-year-old children with congenital scoliosis?, clinical orthopedics and related research, vol.478 (10), pages 2375¿2386 (china).The aim of this single-center retrospective, controlled study is to compare growth-friendly scoliosis surgery and posterior spinal fusion, and asked which technique (1) provides greater correction of spinal deformity, (2) is associated with more surgical complications, and (3) results in greater improvement in pulmonary function tests, hrqol scores, and other patient-reported outcomes? between january 2009 to july 2017, a total of 12 patients (7 male and 5 female), with a median age of 9 years (range, 9 to 11 years), were treated with growth-friendly surgery.Of these, 3 patients were implanted with vertical expandable prosthetic titanium rib (veptr).On the other hand, 24 patients (14 male and 10 female) with a median age of 10 years (range, 9 to 11) were treated with posterior spinal fusion.The follow-up period was a median of 7.2 years (range, 5 to 9) for the growth-friendly group versus median 6.8 years (range, 5 to 8) for the posterior spinal fusion group.The following complications were reported: growth-friendly group: a 9-year-old female patient had a pedicle screw (l3) dislodgement before the second lengthening procedure and the screw was replaced during the lengthening procedure (fig.2).7/12 patients in the growth-friendly group had complications.7 unplanned revision surgical procedures were performed for 7 implant-related complications, including 1 patient with rib cradle migration during veptr treatment.2/12 patients had a rod fracture during distraction period.2/12 patients had a pedicle screw, hook, or rod dislodgement during distraction period.While 1/12 patients had this complication at the definitive spinal fusion.3/12 patients had a proximal junctional kyphosis during distraction period.3/12 patients had a coronal imbalance during distraction period and at definitive spinal fusion.1/12 patients had adding-on (an increase in the number of vertebrae in the measured curve either proximally or distally, combined with a curve increase of more than 6° from the first postoperative radiograph) during distraction period.2/12 patients had a superficial infection during distraction period.This report is for an unknown synthes veptr constructs, unknown synthes veptr superior cradle, unknown synthes lumbar extension, unknown synthes mono/polyaxial screws, and unknown synthes veptr implants.This report is for (1) unk - constructs: veptr this is report 6 of 6 (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11343769
• MDR Text Key: 239823134
• Report Number: 8030965-2021-01116
• Device Sequence Number: 1
• Product Code: MDI
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2021
• 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