MAUDE Adverse Event Report: SYNTHES BRANDYWINE LUMB-EXTENSIONROD RAD 220 SIZ 11 TAN GOL; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.252

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient code (b)(4) used for: the complaint indicated that the plate broke post-op which is likely to require 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.Device history records review was conducted.The report indicates that the: part #497.252 / lot #5236987 manufacturing site: (b)(4).Manufacturing date: 26-jul-2006 no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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.No information about patient status.This complaint involves 1 part.Concomitant devices: unknown scews, qty/part/lot unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Updated information added to complaint.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: 16.Nov.17.Due to investigators decision, the unknown rod will be added to the complaint since it is broken as well.This complaint involves 2 parts.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

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.

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.A device history review, including material and hardness reviews, was performed for the returned implant¿s lot number and no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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, device history review, complaint history review and risk assessment review were performed as part of this investigation.This complaint is confirmed.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.

• Brand Name: LUMB-EXTENSIONROD RAD 220 SIZ 11 TAN GOL
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: 7041447
• MDR Text Key: 92467318
• Report Number: 2530088-2017-10339
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 07611819747623
• UDI-Public: (01)07611819747623(10)5236987
• 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,Followup
• Report Date: 10/25/2017

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: 497.252
• Device Lot Number: 5236987
• 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: 10/25/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 11/16/2017; 12/11/2017; 01/10/2018
• Supplement Dates FDA Received: 12/11/2017; 01/04/2018; 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention