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

Catalog Number	498.108
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6395140
• Report Number: 2530088-2017-10069
• Device Sequence Number: 19176903
• Product Code: NKB
• UDI-Device Identifier: 10705034788883
• UDI-Public: (01)10705034788883(10)7971441
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 498.108
• Device Lot Number: 7971441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/11/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 86