MAUDE Adverse Event Report: SYNTHES HAGENDORF 6.0MM TI CURVED SOFT ROD 75MM; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number	498.142
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight reported as approximately (b)(6).Additional product codes: mni, nkb, kwp, kwq.Therapy date: unknown date in 2005.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: december 19, 2002.No non-conformance reports 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 condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that two (2) 6.0mm titanium curved soft rods 75mm broke.The patient had a click-x implant in 2005 and had all hardware removed (6 screws, 2 rods) due to non-fusion on (b)(6) 2017.During the procedure it was noted via x-ray films that two (2) rods were broken at the same non-union l4-l5 level.No implant was replaced.There was no surgical delay and the broken pieces were removed easily.The procedure was completed successfully with no patient harm.Concomitant medical products: screw (part unknown, lot unknown, quantity 6).This is report 2 of 2 for (b)(4).

• Brand Name: 6.0MM TI CURVED SOFT ROD 75MM
• Common Device Name: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6431183
• Report Number: 3003875359-2017-10141
• Device Sequence Number: 1013179
• Product Code: MNH
• UDI-Device Identifier: 10705034789026
• UDI-Public: (01)10705034789026(10)1145219
• 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
• Report Date (Section B): 03/06/2017

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: 498.142
• Device Lot Number: 1145219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/24/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91