MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI LUMBAR EXTENSION SIZE 13/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT LAMINATE

Catalog Number 497.254

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.This report is for unknown part /unknown lot number.Other udi: (01) unknown (10) lot number unknown.Udi unavailable.Original implant date is unknown.(b)(6).Used for: the device was returned broken, it is unknown if the device broke post-op or during the explant.This incident required additional surgical intervention.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Without a lot number, the device history record review and the investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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 on an event in (b)(6) as follows: it was reported that the plate broke postoperatively on the first hole.Due to investigators desicion, the unknown rod will be added to the complaint since it is broken as well.No information about patient status.This complaint involves 2 parts.Concomitant devices: unknown scews, qty/part/lot unknown.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.The investigation summary indicates that: two lumbar extension rods broke postoperatively.The returned lumbar extension rods were examined and in each instance the complaint conditions were able to be confirmed as the rods were broken at the first hold in each instance.Additionally the first rod (497.252 lot 5236987) was found to have been cut and the second rod (identified as 497.254 based on the number of holes) was found to have a secondary fracture on the rod segment.No definitive root cause was able to be determined with the provided information.The complaint conditions were unable to be replicated as due to post-manufacturing damage.Relevant drawings for the returned devices were reviewed (both current revision and from the time of manufacture): top-level; the design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable due to post-manufacturing damage.No device history review was able to be completed on the second lumbar extension rod as the lot number is unknown; material and hardness review is not applicable for this device as there is no indication that material specifications contributed to the reported complaint condition of broken postoperatively.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, drawing review, complaint history review and risk assessment review were performed as part of this investigation.Synthes manufacturing location was discovered upon receipt of subject device.(b)(4).Device 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.

Manufacturer Narrative

Updated information: device 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

Update, dec.11, 2018: patient is a disabled kid.No further information is available.

• Brand Name: TI LUMBAR EXTENSION SIZE 13/220MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT LAMINATE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7106784
• MDR Text Key: 94476641
• Report Number: 2520274-2017-12680
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• 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,Followup,Followup
• Report Date: 11/16/2017

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
• Device Catalogue Number: 497.254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 01/10/2018
• Supplement Dates FDA Received: 01/04/2018; 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention