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

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

Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown vertical expandable prosthetic titanium rib (veptr)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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: groenefeld, b.And hell, a.K.(2013), ossifications after vertical expandable prosthetic titanium rib treatment in children with thoracic insufficiency syndrome and scoliosis, spine, vol.38 (no.13), pages e819-e823 (germany).The aim of this retrospective study is to evaluate the incidence, time of onset, as well as the underlying factors influencing the occurrence of ossifications in children treated with veptr.Between may 2002 to february 2011, a total of 57 patients, with a mean age of primary surgery was 7.7 years (range 1.3¿18.3), underwent a primary surgery using veptr implant.Repeated lengthening of the prosthesis was performed at intervals of 3 to 14 months.The mean duration of follow-up was 29.8 months (range 1¿101) and the mean number of surgical procedures was 5.9 (range 1¿19).The following complications were reported as follows: a girl patient with myelomeningocele had ossification along the rib cage and at the iliac crest after veptr implantation and removal.A (b)(6) girl had ossifications in the lumbar spine after removal of a veptr laminar hook.13 patients had ossifications, which affects in 92 percent the main load sharing implant of each veptr construct.7 cases involved the lumbar spine, 3 cases involved ribs, and 3 cases involved the iliac crest.The analysis of each single implant showed that the ossifications were at the implants, ¿rib to pelvis on the concave side¿ in 26% (8 from 31, 88% cranial, 12% caudal), at the implants ¿rib to rib on the concave side¿ in 4% (1 from 23, the entire implant), at the implants ¿rib to pelvis on the concave side¿ in 13% (4 from 32, 75% cranial, 25% caudal), and at the implants ¿rib to pelvis on the convex side¿ in 0% (0 from 20).The implants with high load sharing¿¿rib to lumbar spine on the concave side¿ and ¿rib to pelvis on the concave side¿¿showed a higher rate of ossifications than the additional implants¿¿rib to rib on the concave side¿ and ¿rib to pelvis on the convex side.¿ the implants in the rib area ossified in 3% (3 of 106), the implants at the lumbar spine in 23% (7 from 31), and the implants in the pelvic area in 6% (3 from 52, 100% concave side).11 percent of the patients underwent ossification within the first year of treatment.There were ossifications in 12% each between the 13th and 24th month and between the 25th and 48th month and in 14% of the patients (n = 7) with more than 48 months of treatment.In the period of the first 3 operations, 13% of the patients underwent ossification, and in the period of the fourth to including the sixth operation in 11%, in the period of the seventh to including the ninth operation 21%, and with more than 9 operations 0% of the patients (n = 4).After 53 months, 48% of the patients showed some ossifications along the implant (figure 2).The mean magnitude of the ossifications was at the first occurrence 400 mm 2 (range, 48¿1664), at the first lengthening after first occurrence 574 mm 2 (range, 51¿2624; mean increase, 44%) and after an average of 3.9 (range, 1¿10) expansion surgical procedures after first occurrence 1071 mm 2 (range, 75¿3399; mean increase, 168%).5 patients experienced an implant infection with the respective surgical and intravenous drug treatments.53 patients had implant migration.Only 4 patients had no implant migration, but these children only had a follow-up of less than 12 months.11 patients had an implant dislocation, which affected the ribs in 9 cases and the lumbar spine in 2 cases.This report captures the adverse events of ossifications and implant infection.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 3 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8705199
• MDR Text Key: 148215078
• Report Number: 8030965-2019-65396
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: 05/21/2019
• 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