MAUDE Adverse Event Report: SYNTHES BRANDYWINE 6.0MM TI HARD ROD 200MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.108

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier number is (b)(6), patient weight is (b)(6).Event date: unknown.Additional device product codes are mni, mnh, kwp, and kwq.Implant date and (therapy date): unknown date in (b)(6) 2016.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the complaint device lot.Manufacturing location: (b)(4).Manufacturing date: sep 16, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the complaint device.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that patient underwent revision surgery due to a nonunion and two broken 6.0mm titanium (ti) hard rods.Patient had a posterior l2-ilium spine fusion procedure with synthes universal spine system (uss) hardware on an unknown date in (b)(6) 2016.The patient was implanted with two (2) 6.0mm ti hard rods, twelve (12) uss screws of unknown sizes, twelve (12) ti nuts, and twelve (12) 6.0mm ti collars.On an unknown date it was discovered that the patient did not heal at the l5-s1 level and it was found that the rods broke just cranial to the s1 screws.Revision surgery was performed on (b)(6) 2017.There were no fragments generated from the broken rods.The surgeon removed all synthes uss hardware at l2-ilium.The broken rods were removed easily without additional intervention.No additional medical intervention required.The surgeon implanted new synthes uss hardware at l2-ilium.The revision surgery was successfully completed without surgical delay.The patient status/outcome is unknown.Concomitant devices reported: uss screws (partial part# 498.Xxx, lot# unknown, qty 12).Ti nut 11mm width across flats (part# 498.003, lot# unknown, qty 12).6.0mm ti collar (part# 498.010, lot# unknown, qty 12).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Correction to device history record previously reported: review of the device history records showed that there were no issues during the manufacture that would contribute to this complaint condition.There were no non-conformance reports relevant to the complaint.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: 6.0MM TI HARD ROD 200MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 6395129
• MDR Text Key: 69621364
• Report Number: 2530088-2017-10070
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034788883
• UDI-Public: (01)10705034788883(10)7971441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.108
• Device Lot Number: 7971441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 498.003, TI NUT 11MM WIDTH ACROSS FLATS, QTY 12; 498.010, 6.0MM TI COLLAR, QTY 12; UNKNOWN USS SCREWS, QUANTITY 12
• Patient Outcome(s): Required Intervention
• Patient Weight: 86