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U.S. Department of Health and Human Services

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

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SYNTHES BRANDYWINE 6.0MM TI HARD ROD 200MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
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. (b)(6). Additional device product codes are mni, mnh, kwp, and kwq. (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. 0 mm 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. 0 mm ti hard rods, twelve (12) uss screws of unknown sizes, twelve (12) ti nuts, and twelve (12) 6. 0 mm 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, qty 12). Ti nut 11 mm width across flats (part# 498. 003, qty 12). 6. 0 mm ti collar (part# 498. 010, qty 12). This report is 1 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.

 
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Brand Name6.0MM TI HARD ROD 200MM
Type of DeviceORTHOSIS, 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 Key6395140
MDR Text Key69627211
Report Number2530088-2017-10069
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received03/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number498.108
Device LOT Number7971441
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/16/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/10/2017 Patient Sequence Number: 1
Treatment
A 498.003, TI NUT 11MM WIDTH ACROSS FLATS, QTY 12; THE 498.010, 6.0MM TI COLLAR, QTY 12; UNKNOWN USS SCREWS, QUANTITY 12
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