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

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown veptr implants/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.Reporter is j&j employee.(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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this is a case report cited from the source of reference ¿salvage surgery for early onset posterior kyphoscoliosis using eiffel tower vertical expandable prosthetic titanium rib (veptr) construct.¿ at the age of 3 months, the patient was diagnosed by a former surgeon as spinal deformity with curvature progress.At the age of 5 (unknown procedure date), an initial procedure was performed.Diagnosis was syndromic posterior scoliosis which was confirmed by the following symptoms through x-rays: t10-l3: 66-degree rightward bend, and t8-l2: 71-degree backward deformity.The surgeon performed posterior spine short fusion on t10-l3 with unknown device(s).It was postoperatively found the patient had been infected with (b)(6).The surgeon applied antibiotic agents, washing, and two-time debridements.At the age of 6 (unknown procedure date), upper bone healing was confirmed.So, all the implants were explanted, and the infection ameliorated.During the span of two years and five months, however, the spinal deformity had gradually recurred.At the age of 9 (unknown procedure date), the surgeon found 114-degree backward spinal deformity at the top vertebra (52-degree side bend and t12 backward bend).The patient was re-hospitalized to undergo revision procedure for back ache.Further, the surgeon confirmed the following: notable backward deformity was recognized.The erector spinae muscle at the posterior top vertebra had been thinner.It was because sagittal balance had to be sacrificed for excessive lordosis at the posterior top vertebra.The patient claimed dull pain on the lower lumbar spine in order to keep the same posture.At the age of 9 (unknown procedure date), the patient underwent two veptr procedures with eiffel tower construct as follows: primary procedure: top vertebra osteotomy; implanting veptr device(s) on the right.Secondary procedure: implanting veptr device(s) on the left; veptr extension on the right; implanting a cradle on both 7-8 ribs; implanting a s hook on the ilium for interiliac correction between the both ribs and the ilium.During those procedures, no nerve loss or perioperative complications were confirmed.From the age of 9 through 13, the patient had undergone total eight extension procedures (unknown procedure dates).During this period, a revision procedure was also performed for replacing a withdrawn s hook on the ilium.The sagittal plane defectiveness remains, but the patient¿s height has grown by 15.8cm after the aforementioned procedures and reached (b)(6) cm.A final procedure is under planning.No further information is available.Concomitant devices reported: unknown veptr rib hook (part # unknown, lot # unknown, quantity # 1), unknown veptr ii (part # unknown, lot # unknown, quantity # 2), unknown veptr proximal extension (part # unknown, lot # unknown, quantity # 1), unknown veptr distal extension (part # unknown, lot # unknown, quantity # 1), unknown veptr parallel connector (part # unknown, lot # unknown, quantity # 1).This report is for an unknown veptr implants.This is report 1 of 1 for complaint (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.

• Brand Name: UNK - VEPTR IMPLANTS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9038524
• MDR Text Key: 162799170
• Report Number: 8030965-2019-68293
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Patient Sequence Number: 1
• Treatment: UNK - VEPTR IMPLANTS: DISTAL EXTENSION; UNK - VEPTR IMPLANTS: PARALLEL CONNECTOR; UNK - VEPTR IMPLANTS: PROXIMAL EXTENSION; UNK - VEPTR IMPLANTS: RIB HOOK; UNK - VEPTR IMPLANTS: VEPTR II
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR