MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, RIB REPLACEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.This report is for one, unknown veptr rib hook.Part and lot numbers were not available for reporting.Other number¿udi: unknown part number, udi is unavailable.(therapy date): unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Reporting facility phone number is (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 (b)(6) reported the following event: it was reported that there was postoperative migration of the medial proximal rib hook.The initial vertical expandable prosthetic titanium rib (veptr) procedure was performed on an unknown date.On (b)(6) 2016, a planned revision surgery and initial insertion was performed on the patient to explant one (1) rib hook, one (1) rib cap and two (2) distraction locking caps.It was reported that rib cap and two distraction locking caps were not separated from the rib hook.The original two (2) 220 mm distal and proximal rods and one (1) lamina hook remained implanted in patient.Patient was revised with a new rib hook, and to stabilize the revised implants, a transverse rib hook and bar were attached and were successfully implanted.In addition, initial insertion of the lateral rib hooks and vertical expandable prosthetic titanium rib (veptr ii) rods were implanted without any problems.The procedure was prolonged by fifteen (15) minutes, due to intra-operative malfunction of the rib hook (addressed in related complaint (b)(4)).The patient was reported as stable after the procedure.Concomitant devices reported: part: unknown (220 mm) distal and proximal rods, lot# unknown, quantity (2), part: unknown lamina hook, lot# unknown, quantity (1), part: unknown rib cap, lot# unknown, quantity (1), part: unknown distraction locking caps, lot# unknown, quantity (2).This report is for one, unknown veptr rib hook.This report is 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6070432
• MDR Text Key: 58928086
• Report Number: 2520274-2016-15140
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• 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: 10/07/2016
• 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
• Treatment: UNKNOWN DISTR LOCKING CAPS, LOT UNKNOWN, QTY (2); UNKNOWN LAMINA HOOK, LOT UNKNOWN, QTY (1); UNKNOWN RIB CAP, LOT UNKNOWN, QTY (1); UNKNOWN RODS, LOT UNK, QTY 2